maxan anterior cervical plate system - zimmer biomet · 7 surgical technique the ®maxan anterior...

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Surgical Technique MaxAn ® Anterior Cervical Plate System Designed to Help Minimize the Potential for Adjacent Level Ossification • Allows for screw placement up to 30° cephalad on the superior end of the plate and up to 30° caudal on the inferior end of the plate • Plate sizes that begin at 8.0mm hole-to-hole and increase in size by 1.0mm increments • Intuitive instrumentation that places screw holes 1.5mm above and below the treated endplates

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Page 1: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

Surgical Technique

MaxAn® AnteriorCervical Plate System

Designed to Help Minimize the Potential for Adjacent

Level Ossification

• Allowsforscrewplacementupto30°cephaladonthesuperiorendoftheplateandupto30°caudalon the inferior end of the plate

• Platesizesthatbeginat8.0mm hole-to-hole and increase in size by1.0mmincrements

• Intuitiveinstrumentationthatplacesscrewholes1.5mmaboveandbelowthetreatedendplates

Page 2: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

Contents

Introduction................................................ Page1

DesignFeatures.......................................... Page 2

SystemComponents................................... Page 3

Instruments................................................ Page 4

SurgicalTechnique..................................... Page 7 SurgicalApproach................................... Page 9 VertebralBodyDistraction andDiscectomy....................................... Page10 ScrewHolePreparation,Implant and Graft Placement................................ Page11 MaxAn®SystemSingle-LevelTechnique TrialDrillGuides............................ Page11 PreparingtheScrewHoles............ Page12 Plate Selection............................... Page13 Graft Placement............................. Page13 PlateandScrewPlacement........... Page13 MaxAn®SystemMulti-LevelTechnique Option1:TrialDrillGuide.............. Page14 Option2:EndplateDrillGuide........ Page14 Graft Placement............................. Page16 Plate Selection and Placement....... Page16 CephaladScrewInsertion.............. Page16 Preparing the Remaining ScrewHoles................................... Page18 RemainingScrewInsertion............ Page18 ClassicACDFTechnique Graft Placement............................. Page19 Plate Selection and Placement....... Page19 (Optional)TemporaryFixation TackInsertion................................ Page19 EstablishingtheScrewHoles......... Page19 ScrewInsertion.............................. Page 20 ClosureandPost-OperativeCare........ Page21

ImplantRemoval–PrimaryGreenPlates... Page 22 ScrewRemoverInstrument.................... Page 22

ImplantRemoval–PrimaryBluePlates..... Page 23 ScrewRemoverInstrument.................... Page 23

ImplantRemoval–Secondary.................... Page25 ScrewRemoverSleeve............................ Page25 (Optional)LordoticCurvatureofPlate.... Page25

InstrumentCleaning.................................... Page26

Indicationsforuse...................................... Page26

Contraindications........................................ Page 27

Warnings.................................................... Page28

Sterilization Recommendations.................. Page28

OrderingInformation.................................. Page 29

FurtherInformation..................................... Page31

Page 3: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

1

Introduction

TheMaxAn®AnteriorCervicalPlateSystemprovidesa

simple,efficientandinnovativeapproachtoanteriorcervical

plating.Thesystemoffersadecompression-basedtechnique

forcervicalspinestabilizationandintroducesaninnovative

one-levelplatetechniquethatprovidesadirectrelationship

betweenthebonegraft/spacer size and the position of the

plateholes.Theuniqueabilitytoobtainmaximumscrew

angulationandplaceafixedscrewatanyangleupto30°

cephaladonthesuperiorendoftheplateandupto30°

caudalontheinferiorendoftheplateallowsforversatile

screwplacementclosetotheendplates.Notethatthescrews

convergeat10°inthetransverseplaneandarenotintended

tohaveadditionalvariabilityinthatplane.

Thesignificantcephalad-caudalangulationaffordsthe

surgeontheopportunitytochooseasmallerplatetohelp

minimizethepotentialforadjacentleveldegeneration.

Theplateislowprofileandallowsforexcellent

intra-operativevisualizationofthevertebralendplate

andgraft.Thesystemalsoprovidesachoiceoffixed

andvariableself-drillingscrewstoprovidethesurgeon

withmultipleoptions.

Fixed/Variable12mm Fixed/Variable

14mm Fixed/Variable16mm One-Level

Two-Level

Three-Level

Page 4: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

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Design Features

TheDesignRationaleoftheMaxAn®Systemisbased

onaclinicalpaperthatsupportspositioningananterior

cervicalplateatleast5.0mmawayfromtheadjacentdisc

spaceasameansofavoidingthelikelihoodofmoderate

tosevereadjacentlevelossification.1Inordertoachieve

this,theMaxAn®Systemoffersone-levelplatesizesthat

beginat8.0mmhole-to-holeandincreaseinsizeby1.0mm

increments.Inaddition,theMaxAn®Systemallowsforscrew

angulationupto30°cephaladonthesuperiorendofthe

plateandupto30°caudalontheinferiorendoftheplate.

CombinedwiththeabilitytoplaceFixedscrewsintherange

mentionedabove,theresultisanaccurateandreproducible

cervicalplateandscrewplacementthatisasfarawayfrom

theadjacentdiscsaspossible.

TheangulationoftheringsontheMaxAn®platespecifically

allowsforthemaximum30°angulationinthedirectionof

theslotonthering.Thisiswhatallowsfortheextreme

angulationatthecephaladandcaudalendsoftheplate

whereitismostrelevantandnecessary.Itisimportantto

notethattheangulationinthedirectionoppositethesloton

theringislimitedto10°.Inaddition,themiddleholesofa

multi-levelplatefollowthe30°/10°angulation,howeverthe

needforangulationatthoselocationsistypicallynevermore

than10°ineitherthecephaladorcaudaldirection.

TheMaxAn®Systemoffersaone-steplockingmechanism

toinsertandsimultaneouslycapturethebonescrews.This

uniquelockingmechanismeliminatestheneedforadditional

lockingcomponents,andallowsboththeFixedandVariable

bonescrewstobepositionedatanyanglewithinthesweep.

TheFixedscrewsarefixedinplaceviaafrictionlock.Asthe

fixedscrewseatsintothelockingringintheplate,thescrew

headexpandstheringcausingafrictionallockbetweenthe

screw,ringandplate.

1 Park,etal.,DevelopmentofAdjacent-LevelOssificationinPatients

withanAnteriorCervicalPlate,JBJS,2005;87:558-563.

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System Components

TheMaxAn® AnteriorCervicalPlateSystemisananterior

cervicalspinalfixationdevicemadefromtitaniumalloy

(Ti-6Al-4V).Pre-contouredplatesthatconformtothenatural

lordoticcurvatureofthespineareavailableinone,two,

three,orfourlevelconfigurations.Theseofferingsalsorange

from8.0mmto72mminlengthwhenmeasuredfromscrew

holetoscrewhole.Thesystemalsoincludesvariableand

fixedself-drillingbonescrews,whichareavailablein4.0mm

and4.5mmdiametersandseverallengths.

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Instruments

DistractorPinTemplate

Pin/TackInserter

Pin Distractor

TrialDrillGuide

EndplateDrillGuide

SingleBarrelDrillGuide

Page 7: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

5

DoubleBarrelDrillGuide

QuickConnectHandle

Drills

StandardAwl

PunchAwl

Plate Holder

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ScrewRemoverSleeve

Caliper

Bender

Tacks

Instruments (Continued)

ScrewInserter

GreenHandleScrewRemover

GoldHandleScrewRemover

QuickAdjustmentDriver

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Surgical Technique

TheMaxAn® AnteriorCervicalPlateSystemoffersthree

techniquesforscrewholepreparationandimplantandgraft

placement.Thetechniquesaresummarizedinthechart

belowanddetailedinSection3.

MaxAn® System Single Level Technique

(Section 3a)

• Allfourholesarepreparedprior toscrewplacement

• Cephaladscrewsareangledat20° andcaudalscrewsat10°

• Allowsplacementofhardwareas farfromadjacentlevelsaspossible

• Simultaneousgraftsizingand hole preparation

• Platesizeispredeterminedby graft size

MaxAn® System Multi-Level Technique

(Section 3b)

• Twomostsuperiorscrewholesare prepared prior to plate placement

usingeitherthesuperiorholesofatrialdrillguide(20°)orusingtheendplatedrillguide(15°)

• Allowsplacementofmulti-level platesasfarfromadjacentsuperior levelaspossible

• Remainingscrewscanbeplaced atanyangleusingvariousdrill guideoptions

• Noneedforfixationtackstostabilize plateduringscrewholepreparation

Classic ACDF Technique

(Section 3c)

• Holesarepreparedafter plate placement

• DrillGuideoptionsincludeSingle orDoubleBarrelDrillGuides oravariableanglePunchAwl

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Surgical Technique (Continued)

ThetablebelowsummarizesalloftheguideoptionsfortheMaxAn® AnteriorCervicalPlate.

Technique Angulation # of Holes When to Use

Trial Drill Guide MaxAn®Systemsinglelevel

andSuperiorEndofMaxAn®

SystemMulti-Level

20°Cephalad

10°Caudal

4 BeforeGraftandPlate

Endplate Drill Guide MaxAn® Multi-Level 15° 2 BeforeGraftandPlate

Single Barrel Drill Guide MaxAn® Multi-Level,Classic Up to 30° cephalad on

thesuperiorendofplate,

andupto30°caudalon

inferior end

1 After Plate

Double Barrel Drill Guide MaxAn® Multi-Level,Classic Up to 30° cephalad on

thesuperiorendofplate,

andupto30°caudalon

inferior end

2 After Plate

Punch Awl MaxAn® Multi-Level,Classic Up to 30° cephalad on

thesuperiorendofplate,

andupto30°caudalon

inferior end

1 After Plate

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1. Surgical Approach

Thepatientispositionedsupineontheoperativetablewitha

foldedtowelbeneaththeintrascapularregiontomaintainthe

headinslightextension.Theuseofaheadhalterattached

toanoutriggerfortractionmaybehelpful.Iffluoroscopyis

used,itcanbeutilizedatthispointtoconfirmpositioning

andcheckthatthedesiredvertebrallevelscanbeadequately

visualized(Figure1).

Astandardanteriorapproachtothemidandlowercervical

spineisutilized.Thiscanbethroughoneofseveralincisions

withtheexposuretypicallymedialtothecarotidsheathand

lateraltothetracheaandesophagus.Adequatefascialplane

releaseisimportantforoptimalexposure.Afteridentification

ofthediscspacethroughintraoperativeconfirmationof

levelswithx-ray,preparationforanteriorinterbodyfusion

isbegun(Figure2).

Figure1

Figure2

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Surgical Technique (Continued)

2. Vertebral Body Distraction and Discectomy

TheMaxAn® Systemprovidessterile-packedDistraction

PinswhichcanbeusedwiththeLeftorRightPinDistractor

todistractthevertebralbodies.TheDistractionPinsare

loaded into the Distraction Pin/TackInserterbypulling

backonthelockingsleeve,slidingthePinintoplaceand

releasingthesleeve.ThePinscanthenbeinsertedinthe

desiredlocations.

TheDistractionPinTemplateisavailabletoprovideassistance

intheplacementoftheDistractionPinssothattheymaybe

placedasfarawayfromtheadjacentsegmentsaspossible

whileensuringthatthePinswillnotinterferewiththe

TrialDrillGuideusedintheMaxAn® SystemSingle-Level

Technique.Preliminarydiscectomiesareperformedinorder

toseatthecenteringflangeoftheTemplateagainstthe

superiorendplate,relativetothediscspaceandtheinferior

endplate,relativetothediscspace.

OncetheTemplateisinplaceagainstthesuperiorendplate,

aDistractionPinisplacedthroughtheholeandinto

thevertebralbody.TheDistractionPinTemplateisthen

repositionedforPinplacementintothecaudalvertebral

body,sothatthecenteringflangeisplacedagainstthe

inferiorendplate.Careshouldbetakentoensurethatthe

pinsareplaceddirectlyoppositeoneanotheronthemidline

ofthevertebralbody.Thereisnoneedtoperformany

additionalendplatepreparationatthistime.TheTemplate

isthenremoved,leavingthetwoparallelDistractionPins

inplace.

ThePinDistractorisplacedoverthePinsandopenedas

needed.Thediscectomyandresectionofosteophytesisnow

completed,andfurtherpreparationoftheinterbodyfusion

bedorcorpectomyspaceisperformedasindicated.

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3. Screw Hole Preparation, Implant and Graft Placement

3a. MaxAn® System Single-Level Technique

i. Trial Drill Guides

UsingtheTrialDrillGuides,allfourplateholesmay bepreparedpriortoplacingtheplateonthevertebral

bodies,whileatthesametimethegraftsizeneededcanbedetermined.Thisprocedureallowsthescrewholestobeplacedwithexcellentvisualizationand1.5mmaboveandbelowtheendplates,keepingtheplateawayfromtheadjacentdiscs.TheTrialDrillGuideproduces acephaladscrewholeangleof20°andacaudalscrewholeangleof10°.Thescrewsconvergeat10°inthetransverseplane.

Afterperformingadiscectomy,aTrialDrillGuideis placedinthediscspace(Figure3).

TrialDrillGuidesareavailablein5,6,7,8,9and10mm thicknesses.Thevarioussizesaretrialedinthedisc

spaceuntiltheappropriatefitisachieved.SincetheTrialDrillGuideproducesscrewholes1.5mmaboveand1.5mmbelowtheendplate,thecorrespondingplatetobeimplantedwillalwaysbe3.0mmlargerthanthegraftsizechosen.ThefollowingchartmaybeusedtoreferencetherelationshipbetweentheTrialDrillGuideandplatesize.

Trial DrillGuide Size

ColorCode

CorrespondingMaxAn® 1-Level Plate

5.0mm Orange 8.0mm

6.0mm Yellow 9.0mm

7.0mm Green 10mm

8.0mm Purple 11mm

9.0mm Gray 12mm

10mm Black 13mm

NotethattheTrialDrillGuidehasadirectional orientationduetodifferentcephaladandcaudaldrill

guideangulations.Theproperdirectionalorientationisidentifiedbythestickfigureatthetopoftheinstrumentandthe“HEAD”and“FEET”markingsonthedrillguidetubes(Figures4and5).

Figure3

Figure4

Figure5

Page 14: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

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Surgical Technique (Continued)

ii. Preparing the Screw Holes

Oncethecorrectspacersizeisdetermined,theDrillBit

canbeintroducedthroughtheguidebarrelsontheTrial

DrillGuide.TheappropriateDrillBitisattachedtothe

handlewithaquick-connectmechanism.TheDrillBit

sizeisselectedbasedonthecorrespondingbonescrew

size.Thediameteristhesameastheminordiameter

ofthe4.0mmscrews.Bonescrewlengthismeasured

fromtheundersideofthecervicalplateanddoesnot

includetheheightofthescrewhead.Theappropriate

screwlengthcanbeverifiedusingtheScrewGauge

locatedontheScrewCaddy.

NOTE:TheMaxAn®Systemwasdesignedtoallowthe

screwstobeplacedupto30°cephaladorcaudalat

thoseendsoftheplate.Careshouldbetakentoavoid

penetrationoftheadjacentendplate,especiallywhen

usinglongerscrews.

NOTE:DrillBitsandBoneScrewsarecolorcodedby

length.FixedScrewsarefullycolored.VariableScrews

havesilvershaftswithcoloredheads.

Allfourholesarepreparedpriortoplateinsertion

(Figures6and7).Afterdrillingthefirsthole,itis

helpfultodisengagethehandleandleavetheDrillBitin

placetostabilizethetrialwhilethecontralateralholes

aredrilled.Afterdrillingthethirdhole,leavetheDrillBit

intheplace,removethefirstDrillBitandpreparethe

finalhole.

Asanalternativetodrillingthroughthedrillguides,the

StandardAwlmaybeplacedthroughthedrillguides

to pierce the anterior cortex to the minor diameter of a

4.0mmbonescrewandtoadepthof10mm.TheTrial

DrillGuidemayberemovedoncetheholeshave

beenprepared.

Figure6

Figure7

12mm(Light Green)

14mm(Gold)

16mm(LightBlue)

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iii. Plate Selection

Thefourholespreparedforthesingle-levelplatehave

a predetermined location that corresponds to a specific

cervicalplate.SincetheTrialDrillGuidesplacethe

screwholes1.5mmfromthevertebralendplates,the

appropriateplatewillalwaysbe3.0mmgreaterthanthe

height of the graftchosen.Forexample,ifa6.0mmgraft

isused,a9.0mmsingle-levelplatewillbeneeded.The

correct plate size for a given trial is identified on the

handleofeachTrialDrillGuide.

iv. Graft Placement

Pertheappropriatetechnique,thegraftorinterbody

spaceridentifiedbytheTrialDrillGuideisinsertedinto

thediscspace.ThetrialportionoftheTrialDrillGuides

assumesthatthegraftwillbecountersunkby2.0mm.

v. Plate and Screw Placement

Theplateisplacedoverthegraftsuchthatthescrew

holesarevisiblethroughthelockingringsoftheplate

(Figures8and9).Theappropriatebonescrewisloaded

ontheScrewInserter.VariableandFixedscrewscanbe

identifiedbytheircoloringandheadgeometry.Variable

screwsarecoloredontheheadonlyandthecruciate

driveextendsfullythroughtheheadofthescrew.Fixed

screwsarefullycoloredandthecruciatedrivedoesnot

cutthroughtheheadofthescrew.

Attachtheappropriatesizeandstylebonescrewtothe

inserterbyplacingthedistaltipoftheinserterintothe

cruciateontheheadofthescrew.Turntheblackknob

atthetopoftheInserterclockwiseuntilthescrewis

firmlyattachedtotheInserter(Figure10).Insertthe

bonescrewthroughthelockingringintheplate,taking

carenottoexceed5°ofmedial-lateralangulationoffof

vertical(Figure11).

Figure8

Figure9

Figure10

Figure11

Page 16: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

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Advancethescrewuntiltheliponthescrewhead

engageswiththegrooveinsidethelockingring.There

istypicallytactilefeedback,andtheremaybeaudible

feedback,oncethiscapturehasbeenachieved.Atthis

pointthescrewiscapturedtotheplatebutisnotfully

seated.Itisrecommendedtopartiallyinsertatleasttwo

screwspriortofullyseatingeitherone.Thiswillprevent

theplatefromturningasthescrewsarefullyseated.

Continueadvancingthescrewsuntilthetopofthe

screwisflushwiththetopofthelockingring.Thefixed

screwmustbeseatedflushorbelowthetopfaceofthe

lockingringinordertofullyexpandthelockingring

andfixthescrewinthedesiredtrajectory.Similarly,the

variablescrewsmustbeflushorbelowthetopfaceof

thelockingringtoensurethattheplateislaggeddown

tothevertebralbodies.

RemovetheScrewInserterfromthebonescrewby

turningtheblackknobinacounterclockwisedirection

untilthebonescrewdisengages.Ifadjustmenttothe

screwsisneededaftertheScrewInserterhasbeen

disengaged,theQuickAdjustmentDrivermaybeused.

3b. MaxAn® System Multi-Level Technique

Therearetwooptionslistedhereforpreparingthe

cephaladholesinamulti-levelconstructusingthe

MaxAn®SystemMulti-LevelTechnique.

Option 1: Trial Drill Guide

TheTrialDrillGuideisalsousedforthepreparationof

thetwomostsuperiorscrewholesinmulti-levelplate

placements.Itprovidesa20°screwangleandplaces

twoscrewholes1.5mmfromthevertebralendplates.If

theTrialDrillGuideisused,onlythetwomostsuperior

screwholeswillbepreparedpriortoplateplacement.

Option 2: Endplate Drill Guide

TheEndplateDrillGuideisusedforthepreparationof

thetwomostsuperiorscrewholesinmulti-levelplate

placements.Itprovidesa15°screwangle.Similarto

theTrialDrillGuide,theEndplateDrillGuideplacestwo

screwholes1.5mmfromthevertebralendplates,thus

allowingasmallerplatetobeused.

TheDrillBitisattachedtothehandlewitha

quick-connectmechanism.TheDrillBitsizeis

selectedbasedonthecorrespondingbonescrewsize.

Thediameteristhesameastheminordiameterofthe

4.0mmscrews.Bonescrewlengthismeasuredfrom

theundersideofthecervicalplateanddoesnotinclude

theheightofthescrewhead.Theappropriatescrew

lengthcanbeverifiedusingtheScrewGaugelocatedon

theScrewCaddy.

Surgical Technique (Continued)

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Figure12

NOTE:TheMaxAn®Systemwasdesignedtoallowthe

screwstobeplacedupto30°cephaladorcaudalat

thoseendsoftheplate,ifsodesired.Careshouldbe

takentoavoidpenetrationoftheadjacentendplate,

especiallywhenusinglongerscrews.

NOTE:DrillBitsandBoneScrewsarecolorcodedby

length.FixedScrewsarefullycolored.VariableScrews

havesilvershaftswithcoloredheads.

PlacetheTrialDrillGuideorEndplateDrillGuideagainst

thevertebralendplateandintroducetheappropriatedrill

bitthroughtheguidebarrels(Figure12).Advancethe

DrillBitthroughtheguidetothedepthpermittedbythe

stop.Asanoption,theStandardAwlmaybeusedin

placeofthedrillbittopiercetheanteriorcortextothe

minordiameterofa4.0mmbonescrewandtoadepth

of10mm.

12mm(Light Green)

14mm(Gold)

16mm(LightBlue)

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Figure13

Figure14

Figure15

Surgical Technique (Continued)

i. Graft Placement

Aspertheappropriatetechnique,interbodygraftsora

strutgraftcannowbesizedandimpactedintoplace.Any

distractionpreviouslyappliedcanbereleasedatthispoint

toassessgraftstability.

ii. Plate Selection and Placement

ACalipermaybeusedtoidentifytheappropriateplate

length(Figure13).

iii. Cephalad Screw Insertion

VariableandFixedscrewscanbeidentifiedbytheir

coloringandheadgeometry.Variablescrewsarecolored

ontheheadonlyandthecruciatedriveextendsfully

throughtheheadofthescrew.Fixedscrewsarefully

coloredandthecruciatedrivedoesnotcutthroughthe

headofthescrew.

Attachtheappropriatesizeandstylebonescrewtothe

inserterbyplacingthedistaltipoftheinserterintothe

cruciateontheheadofthescrew.Turntheblackknob

atthetopoftheInserterclockwiseuntilthescrewis

firmlyattachedtotheInserter(Figure14).Insertthebone

screwthroughthelockingringintheplate,takingcare

nottoexceed5°ofmedial-lateralangulationoffofvertical

(Figure15).

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17

Advancethescrewuntiltheliponthescrewheadengages

withthegrooveinsidethelockingring.Thereistypically

tactilefeedback,andtheremaybeaudiblefeedback,

oncethiscapturehasbeenachieved.Atthispointthe

screwiscapturedtotheplatebutisnotfullyseated.Itis

recommendedtopartiallyinsertatleasttwoscrewsprior

tofullyseatingeitherone.Thiswillpreventtheplatefrom

turningasthescrewsarefullyseated.

Continueadvancingthescrewsuntilthetopofthescrew

isflushwiththetopofthelockingring.Thefixedscrew

mustbeseatedflushorbelowthetopfaceofthelocking

ringinordertofullyexpandthelockingringandfixthe

screwinthedesiredtrajectory.Similarly,theVariable

screwsmustbeflushorbelowthetopfaceofthelocking

ringtoensurethattheplateislaggeddowntothe

vertebralbodies.

RemovetheScrewInserterfromthebonescrewbyturning

theblackknobinacounterclockwisedirectionuntilthe

bonescrewdisengages.Ifadjustmenttothescrewsis

neededaftertheScrewInserterhasbeendisengaged,the

QuickAdjustmentDrivermaybeused.

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18

Figure16

Figure17

Figure18

iv. Preparing the Remaining Screw Holes

TheSingleandDoubleBarrelDrillGuidessnapintothe

lockingringsoftheplateandcanbeangledupto30°

cephaladonthesuperiorendoftheplateandupto30°

caudalontheinferiorendoftheplate(Figure16).The

SingleandDoubleBarrelDrillGuidessnapintothelocking

ringsoftheplateandcanbeangledanywherewithinthe

40°sweepofeachscrewholeofferedbytheMaxAn® plate

(Figure17).EitheraDrillBitortheStandardAwlcanbe

usedthroughtheSingleandDoubleBarrelGuides.

IfaPunchAwlispreferred,snapitintothelockingrings

ontheplate,angleitatthedesiredtrajectoryanddepress

thespringloadedpunchthroughthebone.ThePunchAwl

andtheStandardAwlwillpiercetheanteriorcortexto

theminordiameterofa4.0mmbonescrewandto

adepthof10mm.

v. Remaining Screw Insertion

AttachtheappropriatebonescrewtotheScrewInserteras

detailedaboveandinsertscrewsintothepreparedholes

(Figure18).

Surgical Technique (Continued)

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3c. Classic ACDF Technique

i. Graft Placement

Aspertheappropriatetechnique,interbodygraft(s)

orastrutgraftcannowbesizedandimpactedinto

place.Anydistractionpreviouslyappliedcanbe

releasedatthispointtoassessgraftstability.

ii. Plate Selection and Placement

ACalipermaybeusedtoidentifytheappropriate

platelength.

iii. (Optional) Temporary Fixation Tack Insertion

Aftertheplatehasbeenpositioned,aTemporary

FixationTackmaybeinsertedtoprovidefixation

whiledrillingholesandinsertingbonescrews.

TheTemporaryFixationTackispositionedutilizing

the Distraction Pin/TackInserter.Thefixationtacks

areloadedintotheTackInserterbypullingbackon

thelockingsleeve,slidingthetackintoplace

andreleasingthesleeve.

TheTemporaryFixationTackisinsertedbyturningthe

TackInserterinaclockwisedirection.Oncethetack

shoulderisfullyseatedintothescrewhole,theTack

Inserterisremovedbypullingbackonthelocking

sleeveandreleasing.Additionalfixationtacksmay

beinserted,ifdesired.

iv. Establishing the Screw Holes

TheSingleandDoubleBarrelDrillGuidessnapintothe

lockingringsoftheplateandcanbeangledupto30°

cephaladonthesuperiorendoftheplateandupto30°

caudalontheinferiorendoftheplate.TheSingleand

DoubleBarrelDrillGuidessnapintothelockingrings

oftheplateandcanbeangledanywherewithinthe

40°sweepofeachscrewholeofferedbytheMaxAn®

plate.EitheraDrillBitortheStandardAwlcanbeused

throughtheSingleandDoubleBarrelGuides.Advance

theDrillBitthroughtheguidetothedepthpermittedby

thestop.

TheappropriateDrillBitisattachedtothehandle

withaquick-connectmechanism.TheDrillBitsizeis

selectedbasedonthecorrespondingbonescrewsize.

Thediameteristhesameastheminordiameterofthe

4.0mmscrews.Bonescrewlengthismeasuredfrom

theundersideofthecervicalplateanddoesnotinclude

theheightofthescrewhead.Theappropriatescrew

lengthcanbeverifiedusingtheScrewGaugelocated

ontheScrewCaddy.

NOTE:TheMaxAn®Systemwasdesignedtoallowthe

screwstobeplacedupto30°cephaladorcaudalat

thoseendsoftheplate,ifsodesired.Careshouldbe

takentoavoidpenetrationoftheadjacentendplate,

especiallywhenusinglongerscrews.

NOTE:DrillBitsandBoneScrewsarecolorcodedby

length.FixedScrewsarefullycolored.VariableScrews

havesilvershaftswithcoloredheads.

12mm(Light Green)

14mm(Gold)

16mm(LightBlue)

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Continueadvancingthescrewsuntilthetopofthescrew

isflushwiththetopofthelockingring.TheFixedscrew

mustbeseatedflushorbelowthetopfaceofthelocking

ringinordertofullyexpandthelockingringandfixthe

screwinthedesiredtrajectory(Figure20).Similarly,the

Variablescrewsmustbeflush,orbelowthetopfaceofthe

lockingring,toensurethattheplateislaggeddowntothe

vertebralbodies.

RemovetheScrewInserterfromthebonescrewby

turningtheblackknobinacounterclockwisedirectionuntil

thebonescrewdisengages.Ifadjustmenttothescrewsis

neededaftertheScrewInserterhasbeendisengaged,the

QuickAdjustmentDrivermaybeused.

Figure19

Figure20

IfaPunchAwlispreferred,snapitintothelockingrings

ontheplate,angleitatthedesiredtrajectoryanddepress

thespringloadedpunchthroughthebone.BoththePunch

AwlandtheStandardAwlwillpiercetheanteriorcortexto

theminordiameterofa4.0mmbonescrewandtoadepth

of10mm.

v. Screw Insertion

TheappropriatebonescrewisloadedontheScrew

Inserter.VariableandFixedscrewscanbeidentifiedby

theircoloringandheadgeometry.Variablescrewsare

coloredontheheadonlyandthecruciatedriveextends

fullythroughtheheadofthescrew.Fixedscrewsarefully

coloredandthecruciatedrivedoesnotcutthroughthe

headofthescrew.

Attachtheappropriatesizeandstylebonescrewtothe

inserterbyplacingthedistaltipoftheinserterintothe

cruciateontheheadofthescrew.Turntheblackknobat

thetopoftheInserterclockwiseuntilthescrewisfirmly

attachedtotheInserter.Insertthebonescrewthroughthe

lockingringintheplate,takingcarenottoexceed5°of

medial-lateralangulationoffofvertical.

Advancethescrewuntiltheliponthescrewhead

engageswiththegrooveinsidethelockingring.There

istactilefeedback,andtheremaybeaudiblefeedback,

oncethiscapturehasbeenachieved.Atthispoint,the

screwiscapturedtotheplate,butisnotfullyseated.Itis

recommendedtopartiallyinsertatleasttwoscrewsprior

tofullyseatingeitherone(Figure19).

Surgical Technique (Continued)

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21

4. Closure and Post-Operative Care

After implantation of the MaxAn® AnteriorCervicalPlate

Systemiscompletedusingoneofthetechniquesdescribed

above,closureisperformedinlayersaccordingtostandard

protocol.Asoftcollarmaybeusedpostoperativelyfor

patientcomfort.Postoperativeradiographsshouldbetaken.

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Figure21

Figure22

Figure23

Implant Removal – Primary Green Plates

Removal of the MaxAn® AnteriorCervicalPlateSystem

isperformedbydisengagingthescrewfromthelocking

ringandthenbybackingthescrewoutwiththeGreen

HandleScrewRemover.

Screw Remover Instrument

1.SeatthecruciatetipoftheScrewRemoverintothe

cruciateonthebonescrew.

2.TurntheblackknobatthetopoftheRemoverclockwise

untilthethreadsontheinnershaftengagewiththe

threadsinthebonescrew.TheScrewRemoverisnow

fullyengagedtothescrew(Figure21).

3.Spinthegreenhandleoftheremoveruntilthesleeve

makescontactwiththering.Continuetospinthegreen

handleuntilthetactileresistanceisincreased.Avoid

over-tighteningthegreenhandleasthismayresultin

strippingthebone(Figure22).

4.HoldthegreenhandleoftheScrewRemoverstillwhile

turningthebluehandlecounter-clockwise(Figure23).

5.Thelockingliponthescrewwilldisengagefromthe

capturegrooveinthering,andthescrewcannowbe

backedoutpastthering.Oncethescrewisnolonger

capturedtotheplate,thegreenhandlenolongerneedsto

beheld.Continueturningthebluehandlecounterclockwise

tobackthescrewcompletelyoutofthebone.

Donotreuseascrewthathasbeenremovedfromthe

lockingring.Confirmthattheslotsontheringsareoriented

inthecephalad–caudaldirectiononcethescrewhasbeen

removed.Iftheyarenot,discardtheplateanduseanewone.

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Figure24

Figure25

Figure26

Implant Removal – Primary Blue Plates

Removal of the MaxAn® AnteriorCervicalPlateSystem

isperformedbydisengagingthescrewfromthelocking

ringandthenbybackingthescrewoutwiththeGold

HandleScrewRemover.

Screw Remover Instrument

1.SeatthecruciatetipoftheScrewRemoverintothe

cruciateonthebonescrew(Figure24).

2.TurntheblackknobatthetopoftheRemoverclockwise

untilthethreadsontheinnershaftengagewiththe

threadsinthebonescrew(Figure25).TheScrew

Removerisnowfullyengagedtothescrew.

3.SpinthegoldhandleontheScrewRemoverdownuntilit

makescontactwiththering(Figure26).Grasptheknurled

portionoftheshaftandturnittoseatthetineonthetip

oftheinstrumentintotheslotinthering.Theshaftis

spring-loadedtofacilitatethisprocess.Thereisablack

linethatrunsdownthelengthoftheshafttohelplocate

thetineintothering(Figure27).Oncethetineatthetipof

theinstrumentisfullyseatedintotheslotofthering,the

goldhandleontheScrewRemovershouldbeadvanced

untiltheresistancebeginstoincreaseslightly.Advancing

thegoldhandleallowsthetinetoslightlyopenthering.

Avoidover-tighteningthesleeveasthismayresultin

strippingofthebone.

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24

Implant Removal – Blue Plates (Continued)

4.HoldthegoldhandleoftheScrewRemoverstillwhile

turningthebluehandlecounterclockwise(Figure28).

5.Thelockingliponthescrewwilldisengagefromthe

capturegrooveinthering,andthescrewcannowbe

backedoutpastthering.Oncethescrewisnolonger

capturedtotheplate,thegoldhandlenolongerneedsto

beheld.Continueturningthebluehandlecounterclockwise

tobackthescrewcompletelyoutofthebone(Figure29).

Figure27

Figure28

Figure29

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25

Implant Removal – Secondary

Screw Remover Sleeve

UsetheScrewRemoverSleevetoremoveaMaxAn® screw

iftheinnerthreadsonthescrewheadhavebeenstripped,

preventingtheScrewRemoverInstrumentfromengaging

to the MaxAn® screw.

1.UsetheQuickAdjustmentDrivertoloosenorbackoutthe

screwtoberemovedapproximatelytwoturns.

2.PlacethetipoftheRemoverSleeveagainsttheringon

theplate.

3.Usingamallet,softlytapthetopoftheScrewRemover

Sleeveuntiltheringdisengagesfromthescrewhead.

4.Oncetheringhasdisengagedfromaroundthescrew

head,theMaxAn® screwcanbeunscrewedwiththeQuick

AdjustmentDriver.

Donotreuseascrewthathasbeenremovedfromthe

lockingring.Confirmthattheslotsontheringsare

orientedinthecephalad–caudaldirectiononcethescrew

hasbeenremoved.Iftheyarenot,discardtheplateanduse

anewone.

(Optional) Lordotic Curvature of Plate

Theamountofpre-contouredlordosisintheMaxAn®

AnteriorCervicalPlateissufficientinthemajorityofcases.

Ifdesired,changescanbemadetothestandardlordotic

curvaturebyusingthePlateBender.Seattheplateinside

thePlateBenderandgraduallydepressthehandlesuntil

thedesiredcurvaturehasbeenachieved.

Thebendshouldbeappliedintheareabetweenthescrew

holesinordertoavoidbendingacrossthescrewholes

themselves.Aswithanytitaniumcervicalplate,avoid

sharpbends,reverseorrepetitivebendsandnotching

orscratchingofthedevice,whichcouldproduce

internalstressesandleadtoearlybreakage.

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26

Indications for Use

TheMaxAn® AnteriorCervicalPlateSystemisintendedfor

anteriorinterbodyscrewfixationofthecervicalspine.The

systemisindicatedforuseinthetemporarystabilization

oftheanteriorspineduringthedevelopmentofcervical

spinalfusionsinpatientswithdegenerativediseaseofthe

cervicalspine(asdefinedbyneckpainofdiscogenicorigin

confirmedbypatienthistoryandradiographicstudies),

trauma(includingfractures),tumors,deformity(defined

askyphosis,lordosis,orscoliosis),pseudarthrosis,

and/orfailedpreviousfusions.Theintendedlevelsfor

treatmentrangefromC2–T-1.

Instrument Cleaning

Forcleaningpurposes,theScrewInserter/Remover

componentsmaybedisassembledbyhand.Unthreadthe

innershaftcounterclockwiseuntiltheinnershafthasexited

thehousing.Thecomponentsmustbesterilizedaccordingto

sterilizationrecommendations.

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27

TheMaxAn® AnteriorCervicalPlateSystemiscontraindicated

inpatientswithspinalinfectionorinflammation;morbid

obesity;mentalillness,alcoholismordrugabuse;pregnancy;

metalsensitivity/foreignbodysensitivity;inadequatetissue

coverageovertheoperativesite;openwoundslocaltothe

operativearea,orrapidjointdisease,boneabsorption,

osteopeniaand/orosteoporosis.Osteoporosisisarelative

contraindicationsincetheconditionmaylimitthedegree

ofobtainablecorrection,theamountofmechanicalfixation

and/orintolerance.

Contraindications

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28

Warnings Sterilization Recommendations

Thisdeviceisnotapprovedforscrewattachmenttothe

posteriorelements(pedicles)ofthecervical,thoracic,or

lumbarspine.Thebenefitofspinalfusionsutilizingany

screwfixationsystemhasnotbeenadequatelyestablishedin

patientswithstablespines.Potentialrisksidentifiedwith

theuseofthisdevicesystem,whichmayrequireadditional

surgery,includedevicecomponentfracture,lossoffixation,

nonunion,fractureofthevertebra,neurologicalinjury,and

vascularorvisceralinjury.SeetheWarnings,Precautions,

andPossibleAdverseEffectssectionsofthepackageinsert

foracompletelistofpotentialrisks.

TheMaxAn® AnteriorCervicalPlateSystemisprovided

nonsterileandmustbesterilizedpriortouse.Allpackaging

materialsmustberemovedpriortosterilization.Thefollowing

steam sterilization parameters are recommended for the

MaxAn®platesandscrews.

Cycle: HighVacuum

Temperature: 270°F(132°C)

Time: 4minutes

DryingTime: 30minutes

NOTE: AllowforCooling

Pleaserefertotheinstrumentinstructionsforusefor

cleaning/sterilizationparameters.

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29

Ordering Information

Standard Implant Kit (14-522991)

Catalog # Description Qty

14-522108 1-Level8.0mmPlate 2

14-522109 1-Level9.0mmPlate 2

14-522110 1-Level10mmPlate 2

14-522111 1-Level11mmPlate 2

14-522112 1-Level12mmPlate 2

14-522113 1-Level13mmPlate 2

14-522114 1-Level14mmPlate 2

14-522116 1-Level16mmPlate 2

14-522118 1-Level18mmPlate 2

14-522120 1-Level20mmPlate 2

14-522220 2-Level20mmPlate 2

14-522222 2-Level22mmPlate 2

14-522224 2-Level24mmPlate 2

14-522226 2-Level26mmPlate 2

14-522228 2-Level28mmPlate 2

14-522230 2-Level30mmPlate 2

14-522232 2-Level32mmPlate 2

14-522234 2-Level34mmPlate 2

14-522236 2-Level36mmPlate 2

14-522238 2-Level38mmPlate 2

14-522240 2-Level40mmPlate 2

14-522336 3-Level36mmPlate 1

14-522339 3-Level39mmPlate 1

14-522342 3-Level42mmPlate 1

14-522345 3-Level45mmPlate 1

14-522348 3-Level48mmPlate 1

14-522351 3-Level51mmPlate 1

14-522354 3-Level54mmPlate 1

14-522357 3-Level57mmPlate 1

14-522360 3-Level60mmPlate 1

14-522363 3-Level63mmPlate 1

14-522366 3-Level66mmPlate 1

Catalog # Description Qty

14-521512 4.0mmx12mmFixedBoneScrew 8

14-521514 4.0mmx14mmFixedBoneScrew 16

14-521516 4.0mmx16mmFixedBoneScrew 8

14-521542 4.5mmx12mmFixedBoneScrew 8

14-521544 4.5mmx14mmFixedBoneScrew 8

14-521546 4.5mmx16mmFixedBoneScrew 8

14-521612 4.0mmx12mmVariableBoneScrew 8

14-521614 4.0mmx14mmVariableBoneScrew 16

14-521616 4.0mmx16mmVariableBoneScrew 8

14-521642 4.5mmx12mmVariableBoneScrew 8

14-521644 4.5mmx14mmVariableBoneScrew 8

14-521646 4.5mmx16mmVariableBoneScrew 8

Fixed/Variable12mm Fixed/Variable

14mm Fixed/Variable16mm

One-Level

Two-Level

Three-Level

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30

Standard Instrument Kit (14-522992)

Catalog # Description Qty

14-522000 ScrewInserter 2

14-522001 ScrewRemover 1

14-521003 LargeHandleScrewRemoverSleeve 1

14-521002 QuickAdjustmentDriver 1

14-521004 QuickConnectHandle 2

14-521012 4.0mmx12mmDrill 2

14-521014 4.0mmx14mmDrill 2

14-521016 4.0mmx16mmDrill 2

14-521030 SingleBarrelHandheldDrillGuide 1

14-521032 DoubleBarrelHandheldDrillGuide 1

14-521035 EndplateDrillGuide 1

14-521038 5.0mmGraftTrialDrillGuide 1

14-521039 6.0mmGraftTrialDrillGuide 1

14-521040 7.0mmGraftTrailDrillGuide 1

14-521041 8.0mmGraftTrailDrillGuide 1

14-521042 9.0mmGraftTrialDrillGuide 1

14-521043 10mmGraftTrialDrillGuide 1

14-521060 Awl(10mminBone) 1

14-521061 PunchAwl(10mminBone) 1

14-521062 PlateHolder 1

14-521063 PlateBender 1

14-521070 DistractorPin/TackInserter 1

14-521071 Tack 6

14-521072 12mmDistractionPins(Qty.2) 2*

14-521074 14mmDistractionPins(Qty.2) 2*

14-521076 16mmDistractionPins(Qty.2) 2*

14-521078 LargeDistractionPinTemplate 1

14-521080 PinDistractor(Left) 1

14-521081 PinDistractor(Right) 1

14-521091 ScrewRemoverwithTine (BluePlateRemoval) 1

*Notpartofkit,tobeorderedseparately

Ordering Information (Continued)

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31

Further Information

CAUTION:FederalLaw(USA)restrictsthisdevicetosaleby

orontheorderofaphysician.

ThisbrochuredescribesthesurgicaltechniqueusedbyAlan

S.Hilibrand,M.D.,K.DanielRiew,M.D.andJeffreyC.Wang,

M.D.Thesurgeonwhoperformsanyimplantprocedureis

responsiblefordeterminingtheappropriateproduct(s)and

utilizingtheappropriatetechnique(s)forsaidimplantationin

eachindividualpatient.

Forfurtherinformation,pleasecontacttheCustomerService

Departmentat:

BiometSpine

310InterlockenParkway,Suite120,

Broomfield,CO80021

303.443.7500•800.447.3625

biometspine.com

Page 34: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

32

Notes:

Page 35: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant
Page 36: MaxAn Anterior Cervical Plate System - Zimmer Biomet · 7 Surgical Technique The ®MaxAn Anterior Cervical Plate System offers three techniques for screw hole preparation and implant

Broomfield,CO•800.447.3625biometspine.com•BSP231030L01/14

©2014EBI,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.,oroneofitssubsidiaries,unlessotherwiseindicated.RxOnly.

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

MaxAn® Anterior Cervical Plate System