Solitaire Anterior Spinal System - Zimmer Biomet · The Solitaire System is also indicated for...

$Page 1: Solitaire Anterior Spinal System - Zimmer Biomet · The Solitaire System is also indicated for treating fractures of the thoracic and ™lumbar spine. The Solitaire System is designed$
Surgical Technique

Solitaire™ Anterior Spinal System

Independent Stabilization for ALIF

• AvailableinTitaniumand

B

Contents

Introduction ..................................... Page 1

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

Instruments ...................................... Page 3

SurgicalTechnique ........................... Page 5 ClosureandPostoperativeCare ........... Page 10 ImplantRemoval .............................. Page 10

ProductInformation .......................... Page 11

IndicationsforUse ........................... Page 15

FurtherInformation ........................... Page 19

1

Introduction

TheSolitaire™AnteriorSpinalSystem,availablein

PEEK-OPTIMA® andTitanium,isdesignedforusewith

autograftandisindicatedforstand-aloneintervertebralbody

fusionatoneortwocontiguouslevelsinthelumbarspine

fromL2toS1.

Product Overview

TheSolitaire™InterbodySpacerassistsfusionsbydeveloping

animmediatemechanicalfixationtoadjacentvertebral

bodieswiththreeacuteconvergentangledcancellousbone

screws.Byprovidingastabileenvironmentwithalarge,

single-chamberedopeningandsubsidenceresistantdesign,

theSolitaire™InterbodySpacerofferssurgeonsanalternative

to360°procedures.

TheSolitaire™InterbodySpacerhasalarge,oblongshape,

withflatgroovedsuperiorandinferiorsurfacesandalarge

medialopening.Lateralwallsareperforatedinthetitanium

implanttoenhancevisualizationandprovideproperimplant

positioning.InthePEEKimplant,tantalummarkerslocated

intheposteriorcornersservetofacilitatevisualizationand

desiredimplantpositioningandanintegratedtitaniumplate

engagesthescrewlockingmechanism.Theposteriorwall

issolidtoprovideastableenvironmentforfusion,while

theanteriorwallisperforated.Thethreadsenablescrews

todevelopafrictionfitwiththeimplantlockingscrewsinto

theInterbodySpacerandpassingthroughthesuperiorand

inferiormedialopeningstofixatetheInterbodySpacerwith

theadjacentvertebralbodies.

TherearethreeSolitaire™InterbodySpacerfootprints.

Thethreeavailablefootprints(narrow–28mmwide,

medium–34mmwide,andwide–40mmwide)allowfor

abetteranatomicalfitandtohelpwithresistance.Theyall

haveaconsistentanteriorend,andlateralcurvesdesigned

toconformtothevertebralanatomy.

Theconsistentanteriorendenablesthesameinstrumentsto

beusedforallimplantfootprints.InterbodySpacerheights

rangefrom10mm–20mmintitaniumand12mm–20mm

in PEEK-OPTIMA®,in2mmincrements,withtwolordotic

angleoptions,6°and12°.

Implantsarecolor-codedforheight,andimplantcolor

iscarriedthroughheight-specificinstrumentation.

Instrumentationincludesinstrumentsforsitepreparation,

implantinsertionandscrewfixation.

TheSolitaire™AnteriorSpinalSystemisindicatedfor

vertebralbodyreplacement(Titaniumonly)andintervertebral

fusion(bothTitaniumandPEEK-OPTIMA®).Whenusedfor

vertebralbodyreplacement,theSolitaire™ Anterior Spinal

Systemisindicatedforuseinthethoracolumbarspine

(i.e.,T10toL5)toreplaceadiseasedvertebralbodyresected

orexcisedforthetreatmentoftumorsinordertoachieve

anteriordecompressionofthespinalcordandneuraltissues,

andtorestoretheheightofacollapsedvertebralbody.

TheSolitaire™Systemisalsoindicatedfortreatingfractures

ofthethoracicandlumbarspine.TheSolitaire™System

isdesignedtorestorethebiomechanicalintegrityofthe

anterior,middleandposteriorspinalcolumneveninthe

absenceoffusionforaprolongedperiod.

Asanintervertebralbodyfusiondevicedesignedforusewith

autograft,theSolitaire™AnteriorSpinalSystemisindicated

forstand-aloneintervertebralbodyfusionatonelevelor

twocontiguouslevelsinthelumbarspinefromL2toS1in

patientswithdegenerativediscdisease(DDD)withupto

GradeIspondylolisthesisattheinvolvedlevel(s).DDDis

definedasbackpainofdiscogenicoriginwithdegeneration

ofthediscconfirmedbypatienthistoryandradiographic

studies.Thesepatientsshouldbeskeletallymatureandhave

hadsixmonthsofnon-operativetreatment.

2

Design Features

Narrow:28mmwide Medium:34mmwide Wide:40mmwide

Acuteshallowscrewangleprovides

strongfixationbyoptimizingthread

contactwithcorticalbone

Designedtoresistsubsidence

bycovering80%oftheendplate

Immediatemechanicalfixation

toadjacentvertebralbody,

withnovertebralcolumnprofile

Large,singlechamberdesign

accommodatesthefusionprocess

Screw Options

• Screwformsfrictionfittolockwithspacer

• 5.5mmdiameterscrewwithlengths20mm,22mm, 25mm,27mm,30mm,35mm(measuredfromthe

baseofthehead)

• Corticalthreadprovidesstrongfixationwithadjacent endplatesandresistspullout

Manyimplantationoptionsofferintraoperativeflexibility.

• Threeimplantfootprints

• Varietyofscrewlengths

• Twolordoticangles(6°,12°)

• 10mm-20mmheights

NOTE:10mmavailableinTitaniumOnly.

20mm 22mm 25mm 27mm 30mm

3

Instruments

MediumWidthTrialNarrowWidthTrial WideWidthTrial

MediumWidthRaspNarrowWidthRasp WideWidthRasp

ModularHandle

InserterGuide

4

Instruments (Continued)

Z-ConnectRatchetHandle Z-ConnectT-HandleRatchet Z-ConnectTorqueLimitingHandle

GuideLockTubes GuideLockAwls GuideLockDrills

BoneGraftMold UniversalandRigidDrills-20mm,25mm

UniversalandRigidAwls-20mm,25mm UniversalandRigidPentalobeDrivers

5

Surgical Technique

Step 1 – Exposure

Obtainanteriorexposurepersurgeonpreference.

Exposeandmarkthemidlineoftheintervertebraldisc

aboveandbelowthediscectomysiteandremovetheentire

intervertebraldisc.Ifperformingapartialvertebrectomy,

removethediscandportionoftheadjacentvertebralbody

orbodiesaccordingtosurgeonpreference.

Step 2 – Distraction

Distractionofthediscectomysiteisimportanttorestore

lordosis,opentheneuralforamen,andstabilizetheimplant.

Removethesuperficiallayersofthecartilaginousendplates.

Thiscanbedonewithavarietyofinstrumentssuchas

scrapers,curettes,andrasps.Adequatepreparationofthe

endplatesisimportanttoenhancevascularsupplytothe

fusionsite.

Step 3 – Trialing

Theoptimalimplantwidthandheightcanbedetermined

byusingthewidthandheighttrials.Thewidthtrialsare

usedfirsttodeterminetheappropriateimplantfootprint

tobeutilized.

SelecttheNarrowWidthTrial,affixtotheModularHandle

andinsertintothediscectomysite.IftheNarrowWidthTrial

istoonarrow,useincrementallywiderfootprintsuntilan

appropriatewidthisachieved.(Figure1)TheTrialscanbe

easilyattachedtothemodularhandlebypullingthepull

pinsonthehandle,thusreleasingthedetentsatthetip.

ThenplacetipinsideslotonTrial.

Oncefootprintwidthisdetermined,selectthe12mmTrial

(ifusingtheTitaniumimplantstartwiththe10mmTrial),

affixtotheModularHandleandinsertintothefusionsite.

IftheTrialistoosmall,useincrementallylargersizesuntil

atightfitisachieved.Thereshouldbenogapsbetween

thepreparedsiteandTrial.Usethelargestsizepossible

toensuremaximumstability.(Figure2)

O.R. Tips:Alateralfluoroimagecanbeutilizedtoillustrate

posteriorendplatecontactwiththeTrial.Each6°implant

isapproximately2.62mmlessattheposteriorendandthe

12°implantsare5.24mmlessposteriorwhencompared

totheanteriorheight.Figure1

Figure2

6

Surgical Technique (Continued)

Step 4 – Endplate Preparation

Oncefinalsizinghasbeendeterminedusingtheappropriate

Trial,utilizetheappropriatesizedTrialRasptocomplete

endplatepreparation.AttachtheModularHandletotheTrial

Rasp,andimpactitintothediscectomysite.Then,usingthe

slaphammer,removetheTrialRasp.Usetheraspinorder

toexposebleedingbone.(Figure3)

CAUTION:Aggressivepreparationoftheendplatemay

removeexcessiveboneandweakentheendplate.

Step 5 – Bone Mold Assembly

AssembletheMoldToptotheMoldBase(Figure4)

Step 6 – Implant Preparation

InsertimplantintoBoneMoldassembly,andfillwithdesired

autograftmaterial,asdeterminedbythesurgeon.Thiscan

befacilitatedthroughuseoftheBoneGraftTamp.

Graft Volume

Height Lordosis Narrow Medium Wide

10 6° 2 3 3 12° 2 3 3

12 6° 3 4 4 12° 3 4 4

14 6° 4 5 5 12° 4 5 5

16 6° 5 6 6 12° 5 6 6

18 6° 6 7 7 12° 6 7 7

20 6° 7 8 8 12° 7 8 8

The Solitaire™ Systemofferstwooptionsforpreparingscrew

holesbasedonsurgeonpreference.

Selecttheinserterguidethatcorrespondstothefinal

implantsizetobeused.Inserterguidesarecolor-codedto

matchaparticularheightofSpacer.Thesameinserterguide

isutilizedforallSpacerfootprintsforaparticularheight.

Figure3

Figure4

7

Figure8

Attachimplanttotheinserterguidebymatchingtheblack

dotontheinnerpartoftheguidetothedotonthetitanium

portionoftheimplant(Figure5).Handtightenscrewon

guide.Attachmodularhandle,andusehexdriverorLong

T-HandleHexguidedrivertosecurelytightenguideto

implant(Figure6).Insertintodiscspace.

O.R. Tip:

Confirmproperorientationofguidetoimplantbydropping

anawlordrilldownoneoftheinserterguidetubes.

Theinstrumentshouldeasilyseatintotheguidewithno

manipulation.(Figure7)

Alternate Screw Prep – Using GOLD Guide Lock Tubes

Followabovestepstoattachtheinserterguidetotheimplant.

Onceinserterguideisattachedtoimplant,insertgoldcolored

guidetubesthroughallthreeholesofinserterguideand

screwintoplace.(Figure8)Insertintodiscspace.

NOTE:Ifusingthistechnique,youmustusetheGOLDTIP

AwlsandDrillsthatareassociatedwiththeguidelocktubes.

Figure7

Figure5

Figure6

8


Step 7 – Implant Insertion

Impacttheimplantintothefusionsite,takingcaretoalign

themedialscrewholewiththepreviouslymarkedmidline.

Releaseanydistractorsinusetoensureimplantisfully

engagedwithendplates.(Figure9)

Figure9

O.R. Tips:

The Solitaire™ InterbodyImplantshouldbecountersunk

1mm-2mminordertoprovideadditionalsafetyforanterior

vascularstructures.Imagingshouldbeusedtoconfirm

thedesiredpositionofthe Solitaire™ InterbodyImplant

priortopreparingscrewholes.

Step 8 – Screw Hole Preparation

InsertUniversalJointorRigidAwlintotheInserterGuide’s

centralscrewholeandimpactuntiltheAwlhitsthepositive

stop.Examinetheimplantsiteusinganintra-operativelateral

X-Raytodetermineappropriatelysizedscrews.The20mm

Awllengthcorrespondsto20mmlongscrews.Usethe

UniversalJointorRigidFishtailDrillwiththeDrillGuideif

desiredtofurtherprepareforscrewfixation.(Figure10)

NOTE:Ifgoldguidelocktubesareattachedyoumustusethe

GOLDtipawlsanddrillsthatcorrespondwiththistechnique.

(Figure11)

O.R. Tips:

Ifendplatesareveryconcave,25mmAwlsand25mm

FishtailDrillsarealsoavailableandcorrespondtothelength

ofthe25mmscrews.

Figure10

Figure11

9

Step 9 – Screw Insertion

AffixanappropriatescrewtotheendoftheUniversalJoint

orRigidPentalobeDriver.(Figure12)

Step 10 – Final Tightening

NOTE:Ifusingthegoldguidelocktubestopreptheholes

theyneedtoberemovedatthistime.

PlacethescrewintothecentralscrewholeontheInserter

Guide.Inserteachscrewuntilsolidengagementofthe

cancellousthreadoccurs.Torqueeachscrewtoensure

engagementofthelockingmechanism.TheTorqueLimiting

Handle‘clicks’atapproximately55in-lbofforce.(Figure13)

Additionalautograftmaterialmaythenbeplacedinfrontof

theimplant.

O.R. Tips:

• Itisrecommendedthatthe Solitaire™ InterbodySpacer shouldbepositionedsothatonescrewisinsertedinto thesuperiorvertebralbodyandtwoscrewsareinserted intotheinferiorvertebralbody.However,testingwas conductedwiththe Solitaire™ InterbodySpacer‘upside down’,soitcanbeusedinthisconfiguration

• InserterGuidemayberemovedintra-operativelyin ordertovisualizepositioningoftheimplantandscrews withinthevertebralbodyunderfluoroscopy

• Finaltightening(torquing)ofscrewscanbedone withorwithoutinserterguideattached

• Usetheslaphammertodisengagethedriverfrom thescrewaftertorquing

Figure13

Figure12

10


Closure and Postoperative Care

Aroutinewoundclosureisthenperformed.

• Routinemonitoringofthevitalsigns,andofthe hemodynamicandneurologicstatusofthepatient

• Painmedication

• NGtubesand/orFoleycathetersarediscontinuedwithin 24-48hours

• Dietisrestrictedtosmallamountsofliquidsuntilreturn ofbowelfunctioniscompleted

• Thepatientisencouragedtoambulateassoonaspossible. Theindividualsurgeondeterminesactivitylevel

• Bracesaretobeusedateachsurgeon’sdiscretion

Implant Removal

Shoulditbecomenecessarytoremovethe Solitaire™ Spacer,

thefollowingguidelinesshouldbeobserved:

1. Softtissueontheanteriorsurfaceoftheimplantshould

beremoved.

2. Initially,UniversalorRigidDriversshouldbeused

toremovescrews.

3. Shouldscrewsbecomestripped,ScrewRemovershould

beusedtoremovescrews.

4. Oncescrewsareremoved,ImplantRemovershould

beutilizedtoremoveimplantfromwoundsite.

11

Product Information

Solitaire™ PEEK Implants – Catalog # 14-530141

Catalog # Description Qty/Kit

14-530011 PEEKImplant–6°12mmNarrow 2




14-530015 PEEKImplant–6°20mmNarrow 0*





14-530025 PEEKImplant–12°20mmNarrow 0*

14-530041 PEEKImplant–6°12mmMedium 2




14-530045 PEEKImplant–6°20mmMedium 0*





14-530055 PEEKImplant–12°20mmMedium 0*

* DenotesSpecialOrderItem


14-530071 PEEKImplant–6°12mmWide 2




14-530075 PEEKImplant–6°20mmWide 0*





14-530085 PEEKImplant–12°20mmWide 0*

12

Product Information (Continued)

Solitaire™ Titanium Implants – Catalog # 55500162


1400-0600 TiImplant–6°10mmNarrow 2





1400-0609 TiImplant–6°20mmNarrow 0*






1400-1209 TiImplant–12°20mmNarrow 0*

1400-0630 TiImplant–6°10mmMedium 2





1400-0639 TiImplant–6°20mmMedium 0*

*DenotesSpecialOrderItem







1400-1239 TiImplant–12°20mmMedium 0*

1400-0650 TiImplant–6°10mmWide 2





1400-0659 TiImplant–6°20mmWide 0*






1400-1259 TiImplant–12°20mmWide 0*

13

Solitaire™ Standard Instruments/Implants –

Catalog # 14-530148


1400-9750 InserterGuide10mm 1





1400-9465 HexGuideDriver 1

1400-9132 20mmUniversalAwl 1

1400-9451 20mmRigidAwl 1

1400-9212 20mmRigidDrill(Fishtail) 1

1400-9222 20mmUniversalDrill(Fishtail) 1

14-530144 PentalobeDriver,Rigid 1

14-530145 PentalobeDriver,U-Joint 1

1400-9270 T-Handle,Ratchet,Z-Connect 1

1300-9004 TorqueT-Handle 1

1400-9490 ScrewRemover 1

14-530106 PentalobeScrews–20mm 10





14-530121 PentalobeScrews–35mm 0*

560169 Ionic®30°DistractorHandleA 1

560170 Ionic®30°DistractorHandleB 1

560189 AISAnteriorDistractorLarge 1

560198 Ionic®SingleTipA 1

560199 Ionic®SingleTipB 1

1000-9007 SlottedMallet 1

1400-9280 StraightHandle,Ratchet,Z-Connect 1

1400-9290 ImplantRemovalTool 1

1000-9010 BoneGraftTamp 1

1400-9167 TemplateMoldBase 1

1400-9170 BoneMoldBase 1

1400-9470 ModularHandle 2


1400-9530 Trial10mm,12°Narrow 1





1400-9539 Trial20mm,12°Narrow 0**

1400-9550 Trial10mm,6°Medium 1





1400-9559 Trial20mm,6°Medium 0**






1400-9569 Trial20mm,12°Medium 0**

1400-9590 Trial10mm,12°Wide 1

1400-9592 Trial12mm,12°Wide 1

1400-9594 Trial14mm,12°Wide 1

1400-9596 Trial16mm,12°Wide 1

1400-9598 Trial18mm,12°Wide 1

1400-9599 Trial20mm,12°Wide 0**

1400-9630 Rasp10mm,12°Narrow 1





1400-9639 Rasp20mm,12°Narrow 0**

*DenotesSpecialOrderItem

**SupplementalTray

14

Product Information (Continued)

Solitaire™ Standard Instruments

Catalog # 14-530148 (Continued)


1400-9659 Rasp10mm,12°Medium 1





1400-9669 Rasp20mm,12°Medium 0**

1400-9690 Rasp10mm,12°Wide 1

1400-9692 Rasp12mm,12°Wide 1

1400-9694 Rasp14mm,12°Wide 1

1400-9696 Rasp16mm,12°Wide 1

1400-9698 Rasp18mm,12°Wide 1

1400-9699 Rasp20mm,12°Wide 0**

Solitaire™ Supplemental Instruments

Catalog # 14-531320


14-530143 T-HandleHexGuideDriver 1

14-531300 GuidelockTubes(Gold) 3

14-531301 GuidelockDrill,20mmRigid 1

14-531302 GuidelockDrill,25mmRigid 1

14-531304 GuidelockDrill,20mmU-Joint 1

14-531305 GuidelockDrill,25mmU-Joint 1

14-531307 GuidelockAwl,20mmRigid 1

14-531308 GuidelockAwl,25mmRigid 1

14-531310 GuidelockAwl,20mmU-Joint 1

14-531311 GuidelockAwl,25mmU-Joint 1

1400-9133 25mmUniversalAwl 1

1400-9452 25mmRigidAwl 1

1400-9213 25mmRigidDrill(Fishtail) 1

1400-9223 25mmUniversalDrill(Fishtail) 1

**SupplementalTray










1400-9580 Trial10mm,6°Wide 1

1400-9582 Trial12mm,6°Wide 1

1400-9584 Trial14mm,6°Wide 1

1400-9586 Trial16mm,6°Wide 1

1400-9588 Trial18mm,6°Wide 1

1400-9589 Trial20mm,6°Wide 1

1400-9599 Trial20mm,12°Wide 1














1400-9680 Rasp10mm,6°Wide 1

1400-9682 Rasp12mm,6°Wide 1

1400-9684 Rasp14mm,6°Wide 1

1400-9686 Rasp16mm,6°Wide 1

1400-9688 Rasp18mm,6°Wide 1

1400-9689 Rasp20mm,6°Wide 1

1400-9699 Rasp20mm,12°Wide 1


15

Indications for Use

TheSolitaire™ and Solitaire™PEEKAnteriorSpinalSystem

isdesignedforusewithautograftandisindicatedfor

stand-aloneintervertebralbodyfusionatonelevelortwo

contiguouslevelsinthelumbarspinefromL2toS1in

patientswithdegenerativediscdisease(DDD)withupto

Grade1spondylolisthesisattheinvolvedlevel(s).DDDis

definedasbackpainofdiscogenicoriginwithdegeneration

ofthediscconfirmedbypatienthistoryandradiographic

studies.Thesepatientsshouldbeskeletallymatureandhave

hadsixmonthsofnon-operativetreatment.

Additionally,theSolitaire™AnteriorSpinalSystemis

indicatedforuseinthethoracolumbarspine(i.e.,T10to

L5)toreplaceadiseasedvertebralbodyresectedorexcised

forthetreatmentoftumorsinordertoachieveanterior

decompressionofthespinalcordandneuraltissues,and

torestoretheheightofacollapsedvertebralbody.The

Solitaire™Systemisalsoindicatedfortreatingfractures

ofthethoracicandlumbarspine.TheSolitaire™System

isdesignedtorestorethebiomechanicalintegrityofthe

anterior,middleandposteriorspinalcolumneveninthe

absenceoffusionforaprolongedperiod.

Description of Device

TheSolitaire™AnteriorSpinalSystemisadevicewithanoval

shapewithperforatedwallsandanopentopandbottom

design.Thesystemconsistsofaspacerwiththreebone

screws.TheSolitaire™PEEKAnteriorSpinalSpacerisa

devicewithanovalshapewithwallsandanopentopand

bottomdesign.ThePEEKsystemconsistsofaspacerwith

radiographicmarkersandbonescrewsforintervertebral

bodyfusion.Thewallsprovidestructuralintegritywhile

theopeningatthetopandbottomofthedeviceallowsfor

bonegrowththroughtheinteriorofthedevice.Thetopand

bottomwallsi.e.,rims,haveserratedteeththatgripintothe

endplatesofthevertebralbodytoreduceimplantmigration.

Thelongitudinalwallslocatedonthetopandbottomofthe

devicearelordoticallyshapedforoptimumsurfacecontact

withthevertebralbody.BoththeSolitaire™ and Solitaire™

PEEKAnteriorSpinalSystemisintendedtoprovidestability

withintheaxisofthespine,therebycreatinganenvironment

forasuccessfulspinalfusionandpainreliefforthepatient.

TheSolitaire™AnteriorSpinalSystemdeviceisavailablein

heightsizesfrom10mm-20mmandismadefromtitanium

alloy(Ti-6A1-4VELI),conformingtoASTMStandardF136.

Instrumentsdesignedforimplantationofthedeviceare

madefromstainlesssteel,conformingtoASTMStandard

F899.TheSolitaire™PEEKAnteriorSpinalSystemisavailable

inheightsizesfrom12mm-20mmandismadefromPEEK-

OPTIMA®asdescribedbyASTMF-2026.Theradio-opaque

markersaretantalumandaremadetothevoluntarystandard

ASTMF-560.Thethreadedinsertismadefromtitanium

alloy(Ti-6Al-4VELI),conformingtoASTMStandardF-136.

Instrumentsdesignedforimplantationofthedeviceare

madefromstainlesssteel,conformingtoASTMStandard

F899andothermedicalgradematerials.

TheSolitaire™ and Solitaire™PEEKAnteriorspacersmay

beusedwiththeSolitaire™ Osseotite®screws.These

screwshavearoughenedsurfacecreatedbytheproprietary

Osseotite®process.

Instructions-for-Use

CAUTION:TheSolitaire™ and Solitaire™ PEEK Anterior

SpinalSystemshouldonlybeimplantedbysurgeonswho

arefullyexperiencedintheuseofsuchimplantsandthe

requiredspecializedspinalsurgicaltechniques.Referto

theSolitaire™ and Solitaire™PEEKAnteriorSpinalSystem

SurgicalTechniqueforcompleteInstructions-for-Use.For

acopyofthesurgicaltechnique,pleasecontactyoursales

representativeattheaddressprovidedbelow.

16

Contraindications

Contraindicationsinclude,butarenotlimitedto,infection,

systemic,spinalorlocalized;morbidobesity;signsof

localinflammation;feverorleukocytosis;metalsensitivity/

allergiestotheimplantmaterials;anymedicalorsurgical

conditionwhichwouldprecludethepotentialbenefitofspinal

implantsurgery,suchastheelevationofsedimentationrate

unexplainedbyotherdiseases,elevationofwhitebloodcount

(WBC),oramarkedleftshiftintheWBCdifferentialcount;

grosslydistortedanatomyduetocongenitalabnormalities;

rapidjointdisease,boneabsorption,osteopenia,and/or

osteoporosis(osteoporosisisarelativecontraindication

sincethisconditionmaylimitthedegreeofobtainable

correction,theamountofmechanicalfixation,and/orthe

qualityofthebonegraft);anycasenotneedingabonegraft

andfusionorwherefracturehealingisnotrequired;anycase

requiringthemixingofmetalsfromdifferentcomponents;

anypatienthavinginadequatetissuecoverageoverthe

operativesiteorwherethereisinadequatebonestock,bone

quality,oranatomicaldefinition;anycasenotdescribedin

theindications;anypatientunwillingtocooperatewiththe

postoperativeinstructions;anytimeimplantutilizationwould

interferewithanatomicalstructuresorexpectedphysiological

performanceandpriorfusionatthelevel(s)tobetreated.

Warnings

Thesurgeonshouldbeawareofthefollowing:

1. Thecorrectselectionoftheimplantisextremely

important.Thepotentialforsuccessisincreasedby

theselectionofthepropersize,shapeanddesignof

theimplant.Thesizeandshapeofthehumanspine

presentslimitingrestrictionsofthesizeandstrengthof

implants.Noimplantcanbeexpectedtowithstandthe

unsupportedstressesoffullweightbearing.

2. Thesurgeonmustensurethatallnecessaryimplants

andinstrumentsareonhandpriortosurgery.Thedevice

mustbehandledandstoredcarefully,protectedfrom

damage,includingfromcorrosiveenvironments.They

shouldbecarefullyunpackedandinspectedfordamage

priortouse.

3. Allinstrumentsmustbecleanedandsterilizedprior

tosurgery.

4. Donotreuseimplants/devices.Whileanimplant/device

mayappearundamaged,previousstressmayhave

createdimperfectionsthatwouldreducetheservicelife

oftheimplant/device.Donottreatpatientswithimplants/

devicesthathavebeenevenmomentarilyplacedinor

usedonadifferentpatient.

5. Properimplantselectionandpatientcomplianceto

postoperativeprecautionswillgreatlyaffectsurgical

outcomes.Patientswhosmokehavebeenshowntohave

anincreasedincidenceofnonunion.Therefore,these

patientsshouldbeadvisedofthisfactandwarnedofthe

potentialconsequences.

6. Postoperativecareisimportant.Thepatientshouldbe

instructedinthelimitationsofhis/herimplantandshould

becautionedregardingweightbearingandbodystress

ontheappliancepriortosecurebonehealing.

7. Patientswithpreviousspinalsurgeryatthelevel(s)tobe

treatedmayhavedifferentclinicaloutcomescomparedto

thosewithoutaprevioussurgery.

8. TheSolitaire™ and Solitaire™ PEEK Anterior Spinal

Systemhasnotbeenevaluatedforsafetyand

compatibilityintheM.R.environment.TheSolitaire™

and Solitaire™PEEKAnteriorSpinalSystemhasnotbeen

testedforheatingormigrationintheM.R.environment.

Indications for Use (Continued)

17

Precautions

Preoperative:Onlypatientsthatmeetthecriteriadescribed

intheindicationsshouldbeselected.Patientconditions

and/orpre-dispositionssuchasthoseaddressedinthe

ContraindicationsSectionshouldbeavoided.Careshouldbe

usedinthehandlingandstorageoftheimplantcomponents.

Theimplantsshouldnotbescratchedorotherwisedamaged.

Implantsandinstrumentsshouldbeprotectedduringstorage

especiallyfromcorrosiveenvironments.Allinstruments

shouldbecleanedandsterilizedbeforeuse.

Intraoperative:Anyinstructionmanualsshouldbecarefully

followed.Atalltimes,extremecautionshouldbeused

aroundthespinalcordandnerveroots.Damagetonerves

mayoccurresultinginalossofneurologicalfunctions.Bone

graftsmaybeplacedintheareatobefused.

Postoperative:Thephysician’spostoperativedirections

andwarningstothepatientandthecorrespondingpatient

complianceareextremelyimportant.Detailedinstructionson

theuseandlimitationsofthedeviceshouldbegiventothe

patient.Ifpartialweight-bearingisrecommendedorrequired

priortofirmbonyunion,thepatientmustbewarnedthat

bending,looseningorbreakageofthecomponentsare

complicationswhichcanoccurasaresultofexcessiveor

earlyweight-bearingorexcessivemuscularactivity.Therisk

ofbending,loosening,orbreakageofaninternalfixation

deviceduringpostoperativerehabilitationmaybeincreasedif

thepatientisactive,orifthepatientisdebilitated,demented,

orotherwiseunabletousecrutchesorothersuchweight

supportingdevices.

Thepatientshouldbewarnedtoavoidfallsorsudden

joltsinspinalposition.Toallowmaximumchancesfor

asuccessfulsurgicalresult,thepatientordeviceshould

notbeexposedtomechanicalvibrationsthatmayloosen

thedeviceconstruct.Thepatientshouldbewarnedof

thispossibilityandinstructedtolimitandrestrictphysical

activities,especiallylifting,twistingmotionsandanytype

ofsportparticipation.Thepatientshouldbeadvisednotto

smokeorconsumealcoholduringthebonegrafthealing

process.Ifanonuniondevelopsorifthecomponents

loosen,bend,and/orbreak,thedevice(s)shouldberevised

and/orremovedimmediatelybeforeseriousinjuryoccurs.

Failuretoimmobilizeadelayedornonunionofbonewill

resultinexcessiveandrepeatedstressesontheimplant.

Bythemechanismoffatiguethesestressescancause

eventualbending,loosening,orbreakageofthedevice(s).

Itisimportantthatimmobilizationofthespinalsurgical

sitebemaintaineduntilfirmbonyunionisestablishedand

confirmedbyradiographicexamination.Thepatientmustbe

adequatelywarnedofthesehazardsandcloselysupervised

toensurecooperationuntilbonyunionisconfirmed.Any

retrieveddevicesshouldbetreatedinsuchamannerthat

reuseinanothersurgicalprocedureisnotpossible.Aswith

allorthopaedicimplants,noneoftheSolitaire™ and Solitaire™

PEEKAnteriorSpinalSystemcomponentsshouldeverbe

reusedunderanycircumstances.

18

Potential Adverse Effects and Complications

Possibleadverseeffectsinclude,butarenotlimited

to,bending,looseningorfractureoftheimplantsor

instruments;lossoffixation;sensitivitytoametallicforeign

body,includingpossibletumorformation;skinormuscle

sensitivityinpatientswithinadequatetissuecoverageover

theoperativesite,whichmayresultinskinbreakdownand/or

woundcomplications;nonunionordelayedunion;infection;

nerveorvasculardamageduetosurgicaltrauma,including

lossofneurologicalfunction,duraltears,radiculopathy,

paralysisandcerebralspinalfluidleakage;gastrointestinal,

urologicaland/orreproductivesystemcompromise,

includingsterility,impotencyand/orlossofconsortium;

painordiscomfort;bonelossduetoresorptionorstress

shielding,orbonefractureat,aboveorbelowthelevelor

surgery(fractureofthevertebra);hemorrhageofblood

vesselsand/orhematomas;malalignmentofanatomical

structures,includinglossofproperspinalcurvature,

correction,reductionand/orheight;bursitis;bonegraft

donorsitepain;inabilitytoresumeactivitiesofnormaldaily

living;reoperationordeath.

Sterilization

TheSolitaire™PEEKspacerandtheSolitaire™ Osseotite®

screwsareprovidedsterile.Theproductisgammaradiation

sterilized.Thepackageshouldbeinspectedpriortouseto

ensurethesterilebarrierhasnotbeencompromised.

Do not resterilize.

TheSolitaire™TitaniumspacerandtheSolitaire™screws

areprovidednon-sterileandmustbesterilizedpriorto

use.Allpackagingmaterialsmustberemovedpriorto

sterilization.Thefollowingsteamsterilizationparameters

arerecommended:

Cycle: HighVacuum

Temperature: 270°F/132°C

Time: 8minutes

Dryingtime: 20minutes

Note: Allowforcooling

Individualsnotusingtherecommendedmethod,temperature

andtimeareadvisedtovalidateanyalternativemethodsor

cyclesusinganapprovedmethodorstandard.

Indications for Use (Continued)

19

Further Information

CAUTION:FederalLaw(USA)restrictsthisdevicetosale

byorontheorderofaphysician.

The Solitaire™ Anterior Spinal SystemSurgicalTechniqueis

presentedtodemonstratethesurgicaltechniqueutilizedby

J.AbbottByrd,III,M.D.Thesurgeonwhoperforms

anyimplantprocedureisresponsiblefordetermining

theappropriateproduct(s)andutilizingtheappropriate

technique(s)forsaidimplantationineachindividualpatient.

Forfurtherinformation,pleasecontacttheCustomerService

Departmentat:

BiometSpine

100InterpaceParkway

Parsippany,NJ07054

973.299.9300•800.526.2579

www.biometspine.com

20

Notes:

C

100InterpaceParkway•Parsippany,NJ07054800.526.2579•www.biometspine.com•BSP228034L06/10

©2010EBI,LLC.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated. U.S.PatentNo.7,077,864.PEEK-OPTIMA®isaregisteredtrademarkofInvibio®BiomaterialSolutions.RxOnly.

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

Solitaire™ Anterior Spinal SystemIndependent Stabilization for ALIF

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