surgical technique · an explanted spinal fixation device should never be reimplanted. even though...

ACPAnterior Cervical Plate System

SURGICAL TECHNIQUE

INTRODUCTION 4

INDICATIONS AND CONTRAINDICATIONS 5

WARNINGS AND PRECAUTIONS 6

IMPLANT DESCRIPTION 7

INSTRUMENTS 10

SURGICAL TECHNIQUE 13

IMPLANT REMOVAL 17

3

ACP TABLE OF CONTENTS

ACP INTRODUCTION

• Anti-migration system

• Large window for graft and anatomical landmark visualization

• 18 mm wide and 2.5 mm thin

• Titanium Alloy plate

• Variable screw angulation

- Cephalad-Caudal Screw angulation ± 10°

- Medial-Lateral Screw angulation ± 10°

• Screws

Standard Self-tapping Screw (A)

Recovery Self-tapping Screw (B)

Standard Self-drilling Screw (C)

• Diameters

Standard screw 4 mm

Recovery screw 4.5 mm

• Color coded for length identification

• Laser mark for diameter identification

4

PLATES

SCREWS

4

Anti-migration system

Large window for graft and anatomical landmark visualization

18 mm wide and 2.5 mm thin

Titanium Alloy plate

Variable screw angulation

- Cephalad-Caudal Screw angulation ± 10°

- Medial-Lateral Screw angulation ± 10°

R= 28 mm

Axial bend radius

ACP

INTRODUCTION

PLATES

SCREWS

Screws

Standard Self-tapping Screw (A)

Recovery Self-tapping Screw (B)

Standard Self-drilling Screw (C)

Diameters

Standard screw 4 mm;

Recovery screw 4.5 mm

Color coded for length identification

Laser mark for diameter identification

A B C

10mm 12mm 14mm 16mm 18mm

sintea PLUSTEK

DATE:REFERENCE CODE: REV:

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pallinaturaH900: HRC 56 - 60

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Present document cannot be reproduced, modified or distributed without express authorisation of Sintea Plustek s.r.l.

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INDICATIONS AND CONTRAINDICATIONS

The Sintea Plustek Anterior Cervical Plate System is indicated for use in the cervical spine (C3-C7) for the following conditions:

• DegenerativeDiscDisease(definedasneckpainofdiscogenicoriginwithdegenerationofthediscconfirmedbyhistoryand radiographic studies)• Spondylolisthesis• Trauma(fractureordislocation)• Spinalstenosis• Deformitiesorcurvatures(scoliosis,kyphosis,lordosis)• Tumor• Pseudarthrosis• Failedpreviousfusion

The contraindications of Sintea Plustek Anterior Cervical Plate System are analogous to those of similar products currently available,andinclude,butarenotlimitedto:

• Activesystemicinfectionorinfectionlocalizedtothesiteoftheproposedimplantationarecontraindicationstoimplantation.• Severeosteoporosisisarelativecontraindicationbecauseitmayresultinimplantsubsidenceandlossoffixation.• Any condition that significantly affects the likelihood of fusion may be a relative contraindication (e.g. cancer, diabetes, osteomalacia,heavysmoker,morbidobesity)andthesurgeonmustevaluatetherelativerisksandbenefitsindividuallywith each patient.• Otherrelativecontraindicationsmayincludementalillness,drugabuse,oralcoholismasthesemaycausethepatienttobe non-compliantwithpost-operativeguidance(e.g.bracingandphysicaltherapy).• Priorfusionatthelevelstobetreated.• Anyconditionnotdescribedintheindicationsforuse.

IftheimplantoftheSinteaPlustekAnteriorCervicalPlateSystemisconsideredthebestsolutionforthepatient,andifthepatientpresentsoneormoreoftheabovecontraindications,itisessentialthepatientbeinformedofthepossiblenegativeconsequencesthat might hinder the success of the procedure.

5

INDICATIONS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Theusageofdissimilarmaterials(e.g.titaniumandstainlesssteel)isstrictlyprohibited.AppropriatelysizedAnteriorCervicalPlatesmustbeusedcorrespondingtopatientneedsanddimensions.Thisdeviceisnotintendedforscrewattachmentorfixationtotheposteriorelements(pedicles)ofthecervical,thoracic,orlumbarspine.Following are specific warnings, precautions, and adverse effects that should be understood by the surgeon and explainedto the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are importantconsiderationsparticular tospinalfixationdevices.Generalsurgical risksshouldbeexplained to thepatientprior tosurgery.

1. Patientswithpriorspinalsurgeryatthelevelstobetreatedmayhavedifferentclinicaloutcomescomparedtothose without a previous surgery.2. PATIENTSELECTION–Inselectingpatientsforinternalfixationdevices,thefollowingfactorscanbeofextremeimportance to the eventual success of the procedure:

a. Apatientmayhavemultiplepaingeneratorsduetoadvancesdegenerationofthespine(e.g.intervertebraldisc,facets,orbonystenosis).Theseconditionsmaybepresentattheindexleveloradjacentlevels.Carefulreviewoftheclinicalrecord,includingradiographicstudiesandapplicablediagnostictests,shouldbeperformedtomaketheappropriatediagnosis.Concomitantconditionsmayreducetheeffectivenessofthesurgeryandthisshouldbediscussed with the patient.

b. Thepatient’sweight.Anoverweightorobesepatientcanproduceloadsonthedevicethatcanleadtofailureoftheimplantorsubsidence.

c. Thepatient’soccupationoractivity.Ifthepatientisinvolvedinanoccupationoractivitythatincludessubstantialwalking,running,lifting,ormusclestrain,theresultantforcescancausefailureoftheimplantorsubsidence.

d. Patients that are non-compliant with postoperative guidance may place too much stress on the implant in the early postoperative period and compromise the maturing fusion mass.

e. Smoking.Patientswhosmokehavebeenobservedtoexperiencehigherratesofpseudarthrosisfollowingsurgicalprocedureswherebonegraftisused.

f. Foreignbodysensitivity.Wherematerialsensitivityissuspected,appropriatetestsshouldbemadepriortomaterialselection or implantation.

Basedonfatiguetestingresults,whenusingtheAnteriorCervicalPlateSystem,thephysician/surgeonshouldconsiderthelevelsofimplantation,patientweight,patientactivitylevel,otherpatientconditions,etc.,whichmayimpactontheperformanceofthissystem.

1. THEIMPLANTATIONOFSPINALFIXATIONDEVICESSHOULDBEPERFORMEDONLYBYEXPERIENCEDSURGEONS WITHSPECIFICTRAININGINTHEUSEOFSUCHDEVICES.THISISATECHNICALLYDEMANDINGPROCEDURE PRESENTINGARISKOFSERIOUSINJURYTOTHEPATIENT.2. PROPERSIZINGOFTHEIMPLANTSISIMPORTANT.Thesurgeonshouldusetrialstodeterminetheappropriateimplanttouse.3. SURGICALIMPLANTSMUSTNEVERBEREUSED.Anexplantedspinalfixationdeviceshouldneverbereimplanted. Eventhoughthedevicemayappearundamaged,itmayhavesmalldefectsandinternalstresspatternsthatmayleadto earlybreakage.4. CORRECTHANDLINGOFTHEIMPLANTISEXTREMELYIMPORTANT.Theoperatingsurgeonshouldavoidanynotching or scratching of the device during surgery. Alterations will produce defects in surface finish and internal stresses which maybecomethefocalpointforeventualbreakageoftheimplant.5. ADEQUATELYINSTRUCTTHEPATIENT.Postoperativecareandthepatient’sabilityandwillingnesstofollowinstructions areoneofthemostimportantaspectsofsuccessfulbonehealing.Thepatientmustbemadeawareofthebody’s responsetotheimplantandhowthefusionmassisexpectedtodevelop.Apatientthatisnon-compliantwithpost- operative guidance is particularly at risk during the early postoperative period.

WARNINGS

PRECAUTIONS

ACP

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IMPLANTS

Hole to Hole

(mm)MaxInteraxis

(mm)Overall length

(mm)1 LEVEL1LevelPlateMaxInteraxis12 ACP-01T512 12 12 20

1LevelPlateMaxInteraxis14 ACP-01T514 14 14 22









2 LEVEL2LevelPlateMaxInteraxis26 ACP-02T513 13 26 34












3 LEVEL3LevelPlateMaxInteraxis45 ACP-03T515 15 45 53










PLATES

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Hole to Hole (mm)

Max Interaxis (mm)

Overall length (mm)

1 LEVEL1 Level Plate Max Interaxis 12 ACP-01T512 12 12 201 Level Plate Max Interaxis 14 ACP-01T514 14 14 221 Level Plate Max Interaxis 16 ACP-01T516 16 16 241 Level Plate Max Interaxis 18 ACP-01T518 18 18 261 Level Plate Max Interaxis 20 ACP-01T520 20 20 281 Level Plate Max Interaxis 22 ACP-01T522 22 22 301 Level Plate Max Interaxis 24 ACP-01T524 24 24 321 Level Plate Max Interaxis 26 ACP-01T526 26 26 341 Level Plate Max Interaxis 28 ACP-01T528 28 28 361 Level Plate Max Interaxis 30 ACP-01T530 30 30 38

2 LEVEL2 Level Plate Max Interaxis 26 ACP-02T513 13 26 342 Level Plate Max Interaxis 28 ACP-02T514 14 28 362 Level Plate Max Interaxis 30 ACP-02T515 15 30 382 Level Plate Max Interaxis 32 ACP-02T516 16 32 402 Level Plate Max Interaxis 34 ACP-02T517 17 34 422 Level Plate Max Interaxis 36 ACP-02T518 18 36 442 Level Plate Max Interaxis 38 ACP-02T519 19 38 462 Level Plate Max Interaxis 40 ACP-02T520 20 40 482 Level Plate Max Interaxis 42 ACP-02T521 21 42 502 Level Plate Max Interaxis 44 ACP-02T522 22 44 522 Level Plate Max Interaxis 46 ACP-02T523 23 46 542 Level Plate Max Interaxis 48 ACP-02T524 24 48 56

3 LEVEL3 Level Plate Max Interaxis 45 ACP-03T515 15 45 533 Level Plate Max Interaxis 48 ACP-03T516 16 48 563 Level Plate Max Interaxis 51 ACP-03T517 17 51 593 Level Plate Max Interaxis 54 ACP-03T518 18 54 623 Level Plate Max Interaxis 57 ACP-03T519 19 57 653 Level Plate Max Interaxis 60 ACP-03T520 20 60 683 Level Plate Max Interaxis 63 ACP-03T521 21 63 713 Level Plate Max Interaxis 66 ACP-03T522 22 66 743 Level Plate Max Interaxis 69 ACP-03T523 23 69 773 Level Plate Max Interaxis 72 ACP-03T524 24 72 80

IMPLANTS

ACP

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Hole to Hole

(mm)MaxInteraxis

(mm)Overall length

(mm)4 LEVEL

4 Level Plate Max Interaxis 60 ACP-04T515 15 60 684 Level Plate Max Interaxis 64 ACP-04T516 16 64 724 Level Plate Max Interaxis 68 ACP-04T517 17 68 764 Level Plate Max Interaxis 72 ACP-04T518 18 72 804 Level Plate Max Interaxis 76 ACP-04T519 19 76 844 Level Plate Max Interaxis 80 ACP-04T520 20 80 884 Level Plate Max Interaxis 84 ACP-04T521 21 84 924 Level Plate Max Interaxis 88 ACP-04T522 22 88 964 Level Plate Max Interaxis 92 ACP-04T523 23 92 1004 Level Plate Max Interaxis 96 ACP-04T524 24 96 1044 Level Plate Max Interaxis 100 ACP-04T525 25 100 1084 Level Plate Max Interaxis 104 ACP-04T526 26 104 112

IMPLANTS

PLATES

8

Hole to Hole (mm)

Max Interaxis (mm)

Overall length (mm)

4 LEVEL4 Level Plate Max Interaxis 60 ACP-04T515 15 60 684 Level Plate Max Interaxis 64 ACP-04T516 16 64 724 Level Plate Max Interaxis 68 ACP-04T517 17 68 764 Level Plate Max Interaxis 72 ACP-04T518 18 72 804 Level Plate Max Interaxis 76 ACP-04T519 19 76 844 Level Plate Max Interaxis 80 ACP-04T520 20 80 884 Level Plate Max Interaxis 84 ACP-04T521 21 84 924 Level Plate Max Interaxis 88 ACP-04T522 22 88 964 Level Plate Max Interaxis 92 ACP-04T523 23 92 1004 Level Plate Max Interaxis 96 ACP-04T524 24 96 1044 Level Plate Max Interaxis 100 ACP-04T525 25 100 1084 Level Plate Max Interaxis 104 ACP-04T526 26 104 112

IMPLANTS

ACP

ACP

8

IMPLANTS

SCREWS L(mm)

SELF-TAPPING SCREW DIAM. 4 mm

Self-tapping Screw Diam. 4 mm – length 10 mm ACP-10T510 10Self-tapping Screw Diam. 4 mm – length 12 mm ACP-10T512 12Self-tapping Screw Diam. 4 mm – length 14 mm ACP-10T514 14Self-tapping Screw Diam. 4 mm – length 16 mm ACP-10T516 16Self-tapping Screw Diam. 4 mm – length 18 mm ACP-10T518 18

SELF-TAPPING SCREW DIAM. 4.5 mm

Self-tapping Screw Diam. 4.5 mm – length 10 mm ACP-11T510 10Self-tapping Screw Diam. 4.5 mm – length 12 mm ACP-11T512 12Self-tapping Screw Diam. 4.5 mm – length 14 mm ACP-11T514 14Self-tapping Screw Diam. 4.5 mm – length 16 mm ACP-11T516 16Self-tapping Screw Diam. 4.5 mm – length 18 mm ACP-11T518 18

SELF-DRILLING SCREW DIAM. 4 mm

Self-drilling Screw Diam. 4 mm – length 10 mm ACP-20T510 10Self-drilling Screw Diam. 4 mm – length 12 mm ACP-20T512 12Self-drilling Screw Diam. 4 mm – length 14 mm ACP-20T514 14Self-drilling Screw Diam. 4 mm – length 16 mm ACP-20T516 16Self-drilling Screw Diam. 4 mm – length 18 mm ACP-20T518 18

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Lmm

SELF-TAPPING SCREW DIAM. 4 mmSelf-tapping Screw Diam. 4 mm – length 10 mm ACP-10T510 10Self-tapping Screw Diam. 4 mm – length 12 mm ACP-10T512 12Self-tapping Screw Diam. 4 mm – length 14 mm ACP-10T514 14Self-tapping Screw Diam. 4 mm – length 16 mm ACP-10T516 16Self-tapping Screw Diam. 4 mm – length 18 mm ACP-10T518 18

SELF-TAPPING SCREW DIAM. 4.5 mmSelf-tapping Screw Diam. 4.5 mm – length 10 mm ACP-11T510 10Self-tapping Screw Diam. 4.5 mm – length 12 mm ACP-11T512 12Self-tapping Screw Diam. 4.5 mm – length 14 mm ACP-11T514 14Self-tapping Screw Diam. 4.5 mm – length 16 mm ACP-11T516 16Self-tapping Screw Diam. 4.5 mm – length 18 mm ACP-11T518 18

SELF-DRILLING SCREW DIAM. 4 mmSelf-drilling Screw Diam. 4 mm – length 10 mm ACP-20T510 10Self-drilling Screw Diam. 4 mm – length 12 mm ACP-20T512 12Self-drilling Screw Diam. 4 mm – length 14 mm ACP-20T514 14Self-drilling Screw Diam. 4 mm – length 16 mm ACP-20T516 16Self-drilling Screw Diam. 4 mm – length 18 mm ACP-20T518 18

ACP

IMPLANTS

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ACP-1200S IMPLANT HOLDER

ACP-1300S TEMPORARYPIN

ACP-1301S PIN HOLDER

ACP-1400S SINGLEFIXEDGUIDEFORDRILLING

ACP-1401S DOUBLEFIXEDGUIDEFORDRILLING

INSTRUMENTS

ACP INSTRUMENT SET

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INSTRUMENTS

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ACP-1300S TEMPORARY PIN


ACP-1400S SINGLE FIXED GUIDE FOR DRILLING

ACP-1401S DOUBLE FIXED GUIDE FOR DRILLING

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INSTRUMENTS

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ACP-1402S ORIENTABLE GUIDE

ACP-1500S AWL

ACP-1610SACP-1612SACP-1614SACP-1616SACP-1618S

TAP 4 mm LENGTH 10 mmTAP 4 mm LENGTH 12 mmTAP 4 mm LENGTH 14 mmTAP 4 mm LENGTH 16 mmTAP 4 mm LENGTH 18 mm

ACP-1700S PROBE

ACP-1800S SCREWDRIVER

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ACP-1402S ORIENTABLEGUIDEFORDRILLING

ACP-1500S CORTICAL AWL

ACP-1501S FIXEDAWL

ACP-1600S TAP

ACP-1700S PROBE


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INSTRUMENTS

ACP

ACP-1402S ORIENTABLE GUIDE

ACP-1500S AWL

ACP-1610SACP-1612SACP-1614SACP-1616SACP-1618S

TAP 4 mm LENGTH 10 mmTAP 4 mm LENGTH 12 mmTAP 4 mm LENGTH 14 mmTAP 4 mm LENGTH 16 mmTAP 4 mm LENGTH 18 mm

ACP-1700S PROBE


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ACP-1801S FIXEDSCREWDRIVER

ACP-1900S PLATE GAUGE

ACP-2000S PLATE BENDER

INSTRUMENTS

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INSTRUMENTS

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ACP-2100S UNIVERSAL HANDLE

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ACP-2100S UNIVERSAL HANDLE

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InstrumentsACP-1900S Plate GaugeACP-1200S Implant Holder

FASE 01

The patient is placed on the operating table in a supineposition.Using the standard surgical approach, expose the vertebralbodiestobefused.Preparethefusionsiteasper theappropriate techniqueforthe given indication.

According to the needed fusion levels and to the patient’sanatomy, choose the most convenient plate, by using thePlate Gauge.

Asfurtherconfirmation,screwtheplateholderintothecentralhole of the selected plate and check the fitting of the implant in the operative theatre.

STEP 01

APPROACH

PLATE SIZE SELECTION

STEP 02

SURGICAL TECHNIQUE

13

SURGICAL TECHNIQUE

ACP

STEP 01

APPROACH

The patient is placed on the operating table

in a supine position.

Using the standard surgical approach,

expose the vertebral bodies to be fused.Prepare the fusion site as per the appropriate

technique for the given indication.

STEP 02

PLATE SIZE SELECTION

According to the needed fusion levels and to the patient’s anatomy, choose the most

convenient plate, by using the Plate Gauge.

As further confirmation, screw the plate

holder into the central hole of the selected

plate and check the fitting of the implant in

the operative theatre.

Instruments

ACP-1900S Plate Gauge

ACP-1200S Implant Holder

13

SURGICAL TECHNIQUE

InstrumentsACP-1200S Implant HolderACP-1300S Temporary PinACP-1301S Pin Holder

InstrumentsACP-2000S Plate Bender

Oncethecorrectplatesizehasbeenchosen,determineplatealignment.ThePlateBendermaybeused togive theplate itscorrectlordoticcurvature,inordertocomplywiththepatientcervicalanatomy.

Aftertheplateisplacedintheappropriatepositionbymeansof the Implant Holder, temporary pins can be inserted intotheextremityholes,inordertoallowatemporarygrabbingoftheplate to thevertebralbodiesand to facilitate thescrewsinsertion without loosening the correct plate position.Thepinsarehandledbymeansoftheproperholder,whichcaneasilyandsafelyseizeandsetthemintheiradequateholes.Insert thefirstpinandfix it into thevertebralbody.Repeatwith the second pin.

PLATE BENDING

TEMPORARY PIN FIXATION

STEP 03

STEP 04

ACP

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InstrumentsACP-1400S SinglefixedguidefordrillingACP-1401S DoublefixedguidefordrillingACP-1402S OrientableguidefordrillingACP-1500S Cortical awlACP-1501S Fixedawl

STEP 05

OPTION 1Insitucannulatedguidesmustbeusedtoensurethecorrecttrajectoryforthescrew.Apply the appropriate Guide on the plate.Singleanddouble,fixedandorientableguidesareavailable.Insert the Awl into the Guide and push down while simultaneously twisting the awl handle.Remove the awl.

OPTION 2A standard drill (2.5 - 3mm diameter) could be used toprepare the screws seats.Selectadrillbitofappropriatelength;thedrillingdepthhastomatch the length of the provided monocortical screws (10mm -12mm-14mm-16mm-18mm);Drilling direction (20° latero-medially and 20° caudo-cranially) iscontrolledby the insitucannulatedguides, thatmustbeusedtoensurethecorrectanglescrewtrajectory.Singleanddouble,fixedandorientableguidesareavailable.

Apply the appropriate Guide on the plate.Insert thedrill bit into the guide anddrill todesireddepth.Remove the drill.

Alternatively,self-drillingscrewscouldbeused.

HOLE PREPARATION

SURGICAL TECHNIQUE

15

InstrumentsACP-1800S ScrewdriverACP-1801S Fixedscrewdriver

Optional InstrumentsACP-1600S TapACP-1700S Probe

Afterhavingremovedtheguides,thescrewscanbeinsertedintotheirseats,usingtheproperscrewdriver.

Connect the selected screw of the appropriate length to the Screwdriver and advance the screw until the head of the screw is fully seated in the plate.

NOTES

•Thankstothedesignofthescrewhead,theantimigrationsystem,characterizedbyadeformablewasher, locks thescrew into the plate.

•Therecoveryscrewmaybeusedasanemergencyscrewwhere the standard screw has stripped the bone and alargerscrewthreadisrequired.

Repeat the same procedure for the remaining screws.Finally,removethetemporarypinsusingtheproperpinholder.

SCREW INSERTION

STEP 06

16

SURGICAL TECHNIQUE

ACP

STEP 06

SCREW INSERTION

After having removed the guides, the screws

can be inserted into their seats, using the

proper screwdriver.

Connect the selected screw of the

appropriate length to the Screwdriver and

advance the screw until the head of the

screw is fully seated in the plate.

NOTES

• Thanks to the design of the screw head,

the antimigration system, characterized by

a deformable washer, lock the screw into

the plate.

• The recovery screw may be used as an

emergency screw where the standard

screw has stripped the bone and a larger screw thread is required.

Instruments

ACP-1800S Screwdriver

ACP-2100S Universal Handle

Repeat the same procedure for the

remaining screws.Finally, remove the temporary pins using the

proper pin holder.

Tap 4 mm Length XXACP-16XXS

Optional Instruments

ACP-1700S Probe

ACP SURGICAL TECHNIQUE

16

InstrumentsACP-1800S ScrewdriverACP-1801S Fixedscrewdriver

FASE 01

Incaseofimplantrevisionorremovalprocedure,itispossibletoremovetheplatesimplybyunscrewingallthescrewsthatfixtheplatetothevertebra.ForscrewremovaltheScrewdrivermustbeused.

Insert the Screwdriver in the screw head and tighten to thread the threaded tip of the inner shaft. Turn the instrument counterclockwisetoextractthescrew.

Afterall thescrewshavebeenremoved, theplatecan thenberemoved.

STEP 01

STEP 02

REMOVE SCREW

REMOVE PLATE

IMPLANT REMOVAL

17

NOTESACP

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SURGICALTECHNIQUEACP–USARev01del22/10/2012

Sintea Plustek LLC

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SISTEMA DI GESTIONECERTIFICATO

UNI EN ISO 9001UNI EN ISO 13485

surgical technique · an explanted spinal fixation device should never be reimplanted. even though...

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