maxan anterior cervical plate system - zimmer biomet · 7 surgical technique the ®maxan anterior...
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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
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
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
2
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.
3
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.
4
Instruments
DistractorPinTemplate
Pin/TackInserter
Pin Distractor
TrialDrillGuide
EndplateDrillGuide
SingleBarrelDrillGuide
5
DoubleBarrelDrillGuide
QuickConnectHandle
Drills
StandardAwl
PunchAwl
Plate Holder
6
ScrewRemoverSleeve
Caliper
Bender
Tacks
Instruments (Continued)
ScrewInserter
GreenHandleScrewRemover
GoldHandleScrewRemover
QuickAdjustmentDriver
7
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
8
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
9
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
10
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.
11
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
12
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)
13
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
14
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)
15
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)
16
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).
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.
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)
19
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)
20
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)
21
4. Closure and Post-Operative Care
After implantation of the MaxAn® AnteriorCervicalPlate
Systemiscompletedusingoneofthetechniquesdescribed
above,closureisperformedinlayersaccordingtostandard
protocol.Asoftcollarmaybeusedpostoperativelyfor
patientcomfort.Postoperativeradiographsshouldbetaken.
22
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.
23
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.
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
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.
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.
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
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.
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
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)
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
32
Notes:
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