%Mecltronic
`
`SOFAMOR DANEK
`
`\/4ERTEwSTACK“”
`PEEK Stackable C.©rpec:t©my Device
`Surgicai Te::}’mique
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`EXHIBIT
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`MSD 1120
`|PR2013—00506
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`|PR2013—00508
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`MICHELSON
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`

`
`:VERTE-STACKT”
`
`PEEK Stackable Corpectomy Device
`
`Table of Contents
`
`Introduction
`
`Introduction ................................................. ..I
`
`PEEK Material Advantages ......................... ..2
`
`VERTE-STACK" Design Features ................. ..3
`
`Surgical Technique ...................................... ..4
`
`Height &. Volume Charts ............................ ..8
`
`Important Information ................................ ..9
`
`The VERTE-STACK” device is manufactured
`
`from medical grade PEEK (polyetheretherketone)
`polymer. It has tantalum wires embedded for
`use as radiographic markers. This device has
`been cleared for lengths from 12mm to 80mm
`and can be used as an individual Add-On piece
`or a construct comprised oftwo Add-On pieces
`and one center piece.
`
`The VERTE-STACK” device is intended for
`
`vertebral body replacement to aid in the surgical
`correction and stabilization ofthe spine. This
`device is indicated for use in the thoracolumbar
`
`spine (T1-L5) to replace and restore the height
`of a vertebral body resected or excised for the
`treatment of trauma or tumor. Two contiguous
`vertebral bodies are the maximum number of
`
`bodies the device is intended to replace. The
`device is intended to be used with supplemental
`fixation: Medtronic Sofamor Danek’s ZPLATE ||""
`
`Anterior Fixation System, LAURAIN DEWALD”
`Anterior Fixation System, TSRH® Spinal System,
`‘ CD HORIZON® Spinal System, DYNALOK
`CLASSIC" Spinal System or GDLH® Posterior
`Spinal System.
`
`

`
`—VERTE-STACK_
`
`PEEK Stackable Corpectomy Device
`
`
`
`
`
`Elastic Modulus
`5
`10
`
`15
`
`Ti-6Al-4V
`
`CFRP
`(transverse)
`
`PEEK
`Material
`
`Cancellous
`Bone
`
`3'7
`
`0.5-5
`
`“ ‘W1 0
`
`8'8
`
`(G Pa)
`
`Ultimate Strength
`
`5000
`
`15000
`
`25000
`
`10000
`
`20000
`
`
`
`
`
`23000
`
`1 4000
`
`VERTE-STACK
`PEEK
`26mm
`
`Titanium
`Expandable
`25mm
`
`Titanium
`Mesh
`25mm
`
`Vertebral
`Body
`
`12400
`
`Load (N)
`
`10000
`
`Fatigue Strength
`5000
`
`10000
`
`VERTE-STACK
`PEEK
`26mm
`
`Titanium
`Expandable
`25mm
`
`Body
`
`Titanium
`Mesh
`13mm
`
`Vertebral
`
`PEEK Mterial Advantages
`
`Radiolucency
`o Easier visualization of bone growth
`- No scatter or artifact with
`CTs and MR|s
`
`Biocompatibility
`Long history of usage:
`- Dental Implants
`- Heart Valves/Stents
`- Artificial Joints
`- Finger Implants
`- Spinal Implants
`
`Bonelike Stiffness
`
`- Modulus of Elasticity closer to that
`ofcancellous bone
`
`-Helps to mitigate ‘stress shielding,’
`which can lead to bone mass loss
`
`Strength
`- Offers greater impact resistance
`- High ultimate strength
`- High fatigue strength
`
`\X/ear Resistance
`
`ZERO wear debris was generated
`during fatigue testing
`
`

`
`VERTE-STACK”
`
`Design Features
`
`General Device
`
`- Versatility
`- 12mm to 80mm heights
`- 0°, 4°, or 8° Iordosis
`
`- Two footprint options
`- Multiple approach possibilities
`- Simplicity
`- Integrated snap-connection
`- Easy to read radiographic markers
`- Biocompatibility
`- PEEK material
`
`- Large, continuous graft area
`- Large endplate contact area
`
`Add-On Pieces
`
`- 12mm to 20mm heights
`-4° or 8° Iordosis
`
`- Radiographic markers
`- Large surface area to reduce subsidence
`- Large area for bone graft
`- Multiple lnserter attachment points
`
`Center Pieces
`
`- 5mm to 40mm heights
`- Integrated snap-connection mechanism
`- Continuous open central column
`for packing bone graft
`- Multiple lnserter attachment points
`
`Radiographic markers — AP X-ray
`
`

`
`
`
`iVERTE-STACK_
`
`PEEK Stackable Corpectomy Device
`
`Step 1.
`Vertebral Body Removal
`
`The affected vertebral body is exposed through
`the appropriate anterior approach. Both discs
`adjacent to the affected vertebral body are
`completely excised and the affected vertebral
`body is removed. Each endplate is then prepared
`
`by cartilage removal and light decortication.
`
`Step 2.
`Restoration ofAnatomy
`
`lfthe VERTE-STACK” device is being used with
`one of the anterior supplemental fixation
`systems, please refer to that particular system's
`surgical technique for further information.
`
`The interbody space is distracted using lateral
`vertebral body screws or the Vertebral Body
`Spreader. The tangs of the Spreader are placed
`on the cortical bone ofthe appropriate endplates
`
`and distraction is applied.
`
`

`
`Step 3.
`Device Selection
`
`The appropriately sized trial endplates (large
`or small) are used to verify the full contact
`between the device and the adjacent vertebral
`bodies. Additional bone may need to be resected
`until a proper fit is achieved. Selection ofthe
`proper endplate angles is based on the anatomy
`ofthe individual patient. Once the proper size
`and angle have been selected, the proper length
`ofthe device is determined by using the calipers
`and the sizing chart.
`
`Step 4.
`Device Preparation
`
`The device is assembled by pressing the
`appropriate Add-On sections onto either end of
`the center cage. [The flat Add-On cage must be
`placed with the angled face of the Add-On piece
`adjacent to the center cage.] The tab mechanisms
`on the center device snap into the triangular
`notches on the Add-On device, holding the
`device securely together. The central channel
`
`of the device is filled with graft.
`
`Snap-connection
`mechanisms
`
`
`
`Center Piece
`
`

`
`
`
`iVERTE-STACK_
`
`PEEK Stackable Cotpectomy Device
`
`Step 5.
`Device Insertion
`
`and Placement
`
`Prior to insertion of the VERTE-STACK” device,
`
`distraction is applied across the defect. The device
`is inserted using the appropriately sized lnserter
`(large or small). Thread the lnserter Rod into
`the appropriate hole on the center device for the
`approach used (anterior, oblique, or lateral). Final
`placement may be refined by attaching the lnserter
`to either Add-On piece. Compression may be
`placed across the construct using the appropriate
`supplemental fixation.
`
`

`
`Step 6.
`Supplemental Fixation
`
`VERTE-STACK” is intended for use only in
`conjunction with supplemental fixation. Please
`refer to the technique manual for the anterior
`or posterior instrumentation selected. For
`detailed information on supplemental fixation,
`the list of systems can be found at the end of
`
`this document.
`
`Step 7.
`Removal of Device
`(if required)
`
`The vertebral bodies adjacent to the
`VERTE-STACK” device are distracted
`
`using a spreader instrument. Reattach the
`lnserter to one ofthe threaded holes on the
`VERTE-STACK” construct. Remove the device
`
`from its position.
`
`

`
`
`A “
`
`
`’VERTE-STACK_
`
`PEEK Stackable Corpectomy Device
`
`0
`Height &. Volume Chart
`
`32=2 -1-.2-1* .2
`
`Hei ht Calculation
`
`Device Height
`
`Add-On
`
`Center Piece
`
`Add-On
`
`.
`—--"T
`l
`.
`Angle
`Hflsht
`
`|
`
`1
`
`-2 A
`'
`1. 4
`'
`_‘
`
`s
`
`'
`
`4*’
`4
`'[l
`
`M —
`» 3:’
`,
`"' 3‘
`W '
`,1 3
`"‘
`
`l
`
`Add-On Center Add.on
`Piece
`Piece
`Piece
`mm
`mm
`mm
`12
`14
`16
`18
`20
`12
`12
`14
`12
`
`5
`5
`5
`10
`
`5
`10
`5
`10
`5
`1o
`5
`10
`5
`20
`5
`20
`20
`20
`20
`30
`30
`
`12
`14
`14
`12
`
`15
`14
`15
`14
`13
`15
`18
`16
`20
`12
`20
`14
`14
`16
`16
`12
`14
`
`14
`12
`15
`14
`15
`14
`18
`16
`18
`12
`20
`12
`14
`14
`16
`12
`12
`
`Large
`Sma||
`Volume Volume
`cc
`cc
`3
`5
`3
`6
`4
`7
`4
`7
`4
`8
`4
`9
`5
`9
`5
`10
`5
`10
`
`5
`5
`5
`6
`5
`5
`7
`6
`7
`6
`7
`6
`7
`7
`7
`7
`7
`
`11
`11
`12
`11
`12
`12
`13
`13
`14
`12
`15
`13
`14
`14
`15
`15
`15
`
`14
`14
`16
`12
`12
`14
`
`14
`16
`16
`18
`18
`20
`
`30
`30
`30
`40
`40
`40
`
`40
`
`40
`40
`40
`40
`
`14
`16
`16
`12
`14
`14
`
`15
`
`18
`18
`20
`20
`
`8
`8
`8
`8
`8
`9
`
`9
`9
`10
`10
`11
`11
`
`16
`"I7
`17
`17
`18
`18
`
`19
`
`20
`21
`22
`23
`
`’
`
`Lordotic Add-On
`
`8' Device
`Lordotic
`Add-On Top
`
`4' Device
`Lordotic
`Add-On Top
`
`0' Device
`Flat
`Add-On Top
`
`Small Size 26mm x 24mm
`Wall Thickness: 5mm
`
`Large Size 36mm x 28mm
`Wall Thickness: 5mm
`
`Lordotic
`Add-On Bottom
`
`Flat
`Add-On Bottom
`
`Flat
`Add»On Bottom
`
`

`
`Important Information on the VERTE-STACK” Spinal System
`The VERTESTACK“ Spinal System is intended for vertebral
`replacement to aid in lhe surgical correction and stabilization of the spine. This
`pa
`n .
`system is indicated for single and twolevel use only in the thoracic and lumbar anterior spine.
`grityglcigt NOTE: Although the physician is the learned intermediary, the important medical information given in this document should be conveyed
`PATIENT’ INFORMATION: The internal fixation device used in our recent spinal surgery is a plastic polymer implant that attaches to the bone and
`stabilization of the spine. This system is indicated for single level and two-level anterior use front
`1 to L5 only.
`aids in the healing of bone grafts. The yEitlEvSTAcK".Spinal
`tam is intended for vertebral both replacement to aid in the surgical conectlon and
`CAUTIDTI: Federal In: (USA) restrict: these devices to sale by or on the order of a physician .
`CAUTION: For use on or bythe order of a physician only.
`other precpentive. intraoperafwe, and postoperative wamings and precautions are as follows:
`Implant selection:
`are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human
`nus. nless
`The selection of the pmper size, shape and design ofthe implant for each patientls crucial to the success ofthe procedure. Plastic polyrgieri
`lants
`great care is taken in patient selection. proper placement of the irnphnt, and postoperative management to minimize stresses on the ‘implant, such
`result in fu
`erlnjury or the need to remove the device prematurely.
`stresses myyrause metal fatigue and consequent breakage, bending or loosening of the device before the healing process is complete, which may
`PREOPERATIVE:
`1. only patients that meet the criteria described in the indications should be selected.
`2. Patient conditions and/or pierispositions such as those addressed in the aforementioned contraindications should be avoided.
`3. care should be used in the handling and storage of the implant components. The imphnts should not be scratched or damaged. implants and
`instruments should be protected during storage especially front corrosive environments.
`:“
`Further information on the use of this system wil be made available on request.
`5. Since mechanical
`its are irwoived, the surgeon should be familiar with the various components before using the eqiiprnerit and should
`personally assemb e the devices to verify that all parts and necessary instruments are present before the surgery begins
`she
`be avaihble at the time of surgery, including sizes larger and smallerthan those expemed to be used.
`6. The‘type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate inventory of implant sizes
`7. All parts should be cleaned and sterilized before use. Additional components should be avadable in case of an unexpected need
`INTRADPERATIIIE:
`1. The instructions in any airailable applicable surgical technique manual should be rrrrefully followed.
`nc ons.
`2. at at; times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological
`3. Breakage, slippage, or misuse of instruments or ‘implant components may cause injury to the patient or operative personnel.
`4. To assure proper fusion below and around the location of the iristrumentafion, a bone graft should be used. Bone graft must be placed in the
`area to be fused and graft material must extend from the upper to the lower vertebrae being fused. when using the VERTE-STACK" device,
`gratis contairiirig autogenous bone should be used.
`5. Bone content should not be used since this material will make removal of the components difficult or impossible.The heat generated from the
`curing process may also cause neurologic damage and bone necrosis.
`
`g
`g
`‘
`POSTDPERATTVE:
`The physician’: postoperative directions and warnings to the patient and the corresponding patient compliance, are extremely important.
`1. Dotaied instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or
`required prior to him bony union, the patient must be warned that bending, loosening or breakage of the device are complications which can
`occur as a result of excessive wei ht bearing or muscular activity. The risk of bendl
`, loosening, or breakage of alerhporary internal fixation
`to use crutches or other weight supporting evioes. The patient
`ould be warned to ave‘
`falls or sudden lofts in spinal position.
`device during postoperative rehab: itation in
`be increased if the
`dam is active, or if thenpatrent is debilitated. demented or otherwise unable
`2. To allow the maximum chances for asuccessful surgical result. the patient or device should not be exposed to_mechanical wbratjons that may
`loosen the device construct. The patient should be warned of this possibi'
`and instructed to Emit and restrict physical activities, a
`eclalty
`lifting and twisting inobons and anytype of sport participation. The patient 5 uuld be advised not to smoke or consume excess aicoho during
`the bone graft healing process.
`3. The patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical
`mtnction in body motion.
`
`these stresses can cause eventual bending, loosenin ,or brcalrage of the device. it is important that irnmobiization of the union is establi
`‘ed
`4. Failure to immobilize a delayed or non-union of bone wil result in excessive and repeated stresses on the implant. By the mechanism of fatigue
`and confirmed by roentgenographic examination.
`re there is a non-union, or if the components loosen, bend, and/or break, the device
`should be revised and/or removed immediately before serious inrury occurs.
`5. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
`PACKAGING:
`orients should be intact upon receipt If a loaner or consignmem system is used, all sets should be carefully
`Packages for each of the co
`checked for completeness an al components should be carefully checked for lack of damage prior to use. Damaged acliages or products
`should not beused, and should be returned to Medtronic Sofamor Danelc Remove all packaging material pnorto ste rzahon only sterile
`implants and instruments should be used in surgery. Always immediately resteriize all implants and ‘nstruments which have been previously in
`the operation area. This process must be performed before handling or returning products to Medtronic Sofamor Danelc
`CLEANING AND DECDN'I'AIAlNATION:
`Unless just removed from an unopened Medhonic_Sofamor Danalr package, all instruments and implants must be disassembled, if applicable,
`and cleaned using neutral cleaners before steriizabon and introduction into a sterile surgical field or (if applicable return of the product to
`Medtronic Sofemor Dariek_ Cleaningand rfisinfecting of irstrunients can be performed with aldehyde-free solve
`at higher temperatures
`cleaning and deoontarnrnehon must include the use of neutral cleaners followed by a deionized water rinse.
`
`devices, partlcularty nah-umenfa; these solutions about not be used.
`ltrita: certain clear-ilny solution: such as those containing lonnalln, glutanldenyde, bleach and/or other alhllne cleaner: may damage some
`Also, many Instruments require dlsaseembly before cleaning.
`All products should be treated with care.
`improper use or handling may lead to damage and/or possible improper functioning of the device.
`STERILIZATION:
`
`Unless marked sterile and clearty labeled as such in an unopened sterile pgclrage provided by the company, all imphnts and instruments used
`plac
`in the operative field.
`or at
`Ste
`Assurance Level, these products are recommended to be steam sterilized by the hospital using
`in so
`fy I.‘IJ.lI§l be sterilized by the ho
`italrgrior to use. Remove al par: ging materials prior to start ization. only sterie products should be
`one of the three sets of process parameters be ova
`mEmj
`i
`
`
`
`
`
`
`variables involved in sterilization. each medical facility should calibrate and validate the sterilization process (eg.
`NOTE Because of the
`temperatures, times) used or their equipment ‘For outside the United States, some non-U.s. Health care Auttioritios recommend steriization
`aoconfing to these parameters so as to minimize the potential risk of transmission of cruutzfeldt—.lalrob rhsease, espechlly of surgical instruments
`that could come into contact with the central nervous system.
`
`
`
`
`
`PRODUCT I2IJIilPlAlllT$_:
`Any Health _Care Professional (e.g., customer or usor_of this system of products). who has any complaints or who has experienced any
`dissatisfaction in the product quality, ide
`, durability, retiabii
`, safety, effectivenws and/or performance, should nottly the distributor,
`Medbonic Sofamor Danelc Further, it any o the implanted spin
`system componentfsl ever 'malfunctions',
`.e.. does not meet any of
`its performance specifications or otherwise does not perform as intended , or is su
`ected of doing so, the
`stnbutor should be notified
`immediately. If
`Medtronlc sofernor Danelr product ever ‘malfunctions and may
`e caused or contributed to the death or serious injury of
`a patient. the dist butor should be notified immediately by telephone, FAX or written correspondence. when fiirig a complaint please provide the
`componentlsl name and number, lot numberfs). your name and address, the nature of the complaint, and notification ofwhetber awritten report
`from the distributor is requested.
`
`_
`FURTHET INFORMATION:
`Recomrriendeddiieclions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is
`needed or required. please contact
`IN THE USA
`IN EUROPE
`Diremor. Customer Service Division
`SDFAMDR SNC"
`MEDTRONIC SOFAMOR DANEK USA
`13. rue de la Perdrix
`T800 Pyramid Place
`93290 TREMBLAV EN FRANCE
`Memphis, Tennessee 38132
`"authorized representative
`USA
`Medtronlc Sofamor SNC-RCS Bobigrry
`Telu hone: 800-875-3133 or 901-396-3133
`B.6I7.320.486
`Tele ax 901-3960356 or 901—33Zv392D
`NAF 331 8
`Tel
`hone: 33-149-38-80~OO
`Tel
`1 33449-38-8001
`02002 Medtronlc solanior Derrek USA, inc. All right: reserved.
`
`>'.°’F‘.‘>$‘.'°.-‘
`
`a blood count (W80), or a marked
`congenital abnurnia ‘ ‘es. elevation of sedimen
`‘ n relu unexplained by other diseases, elevation
`,_such as the presence of tumors or
`Any medical or sur ical condition which would recludo the potential benefit of spinal implant sugge
`left shift in the WBC differential count
`8. Rapid ioint dseaso. bone absorption, osteopenia, eridlor osteo orosis. Osteoporosis is a rehthre conlreindicatiori since this condition may fimlt
`the degree of obtainable correction and/or the amount of m anical fiiation.
`9. Suspected or documented metal allergy or intolerance.
`to. Any case needing to mix metals from different components.
`Ill 00.
`11. my pnatient tiaving inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical
`12. Any case not described in the ‘vidications.
`13. Any patient unwilling to cooperate with postoperative instructions.
`14. These devices must not be used for petfiatric cases, nor where the patient still has general slrelelal growth.
`contraindications of this device are consistentwith those of other spinal systems.
`
`3.
`
`.“">‘t'-7’9‘!>
`
`.
`POSSIBLE ADVERSE EVENTS:
`All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
`instrumentation, a isting of possible atmrsu events orcomplications includes, but '5 not hmlted to:
`1. Early or late loosening of the components. Implant migration.
`2. Disassombty, bending, and/or breakage of any or all of the components.
`E8356.
`fioreign body (allergic) reaction to the implants, debris, corrosion producs, including metallosis, staining, tumor formation and/or autoimmune
`infection.
`Dural tears, pseudomeningocele, fistula, persistent CSF lealiage, meningitis.
`Tissue or nerve damage, irrigation, and/or pain caused by improper positioning and placement of implants or instruments.
`pearance
`Loss of neurol
`ical function, including paralysis (complete or incomplete), dysesthesia.
`resthesia, anesthesia, araasthesla,
`or fa(1TGUIDp€ii'I.yg. and/or the development or continuation of pain. numbness. neuronia, ti
`ing sensation, sensory Iigss and/or spgsprns.
`cauda uqulna syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparcsis, reflex deficits, aiechnoiditis,
`and/or muscle loss.
`Scar formation possibly causing neurological compromise around nerves and/or pain.
`Urinary retention or loss of bladder control or other types of urological system compromise.
`Boriu loss or decrease in bone density, possibly caused by stress shielding.
`Subsidence of the device into vertebral body(ies).
`Postoperative change in spinal curvature. loss of correction, hH'9Iil, and/or reduction.
`ar
`rving.
`of any potenthl growth of the operated portion of the spine. Loss of spinal mcbiity or function. Inability to perform the activities of
`Norrunion (or pseudarthrosis). Delayed union. Mal-union.
`siteal. above, and/or below e level of surgery.
`Fracture, microfracture, rewygfion, damage, penetration, and/or retropulsion of airy spinal bone, of the bone graft, or at the bone graft harvest
`Graft donor site complications including pain, fracture, infection. or wound healing problems.
`Herniated nucleus pulposus, disc tfisruption or degeneration at, above, or below the level of surgery.
`llsus, gastritis, bowel obstruction or othertypes of gastrointestinal system compromise.
`Hemorrhage, hematome, occlusion, seioma, edema, embolism,‘ stroke, excessive bleeding. phlebius damage to blood vessels, or
`cardiovascular system compromise. Wound necrosis or wound dehtsconce.
`Reproductive system compromise, including steriity, loss of consortium, and sexual dysfunction.
`Development of respiratory problems, o.g., pulmonary embolism, amleclasls, bronchitis, pneumonia, etc.
`change in mental status.
`. Death.
`Note: Additional surgery may be necessaryto correct some of these anticipated adverse events.
`INARIIOIG AND PRECAUTIONS:
`-STACK" evlce must be used
`compromise the results. This evice
`stem is not intended to be the sole means of spinal support. The
`where other‘patient conditions may
`A successful result is not
`s achieved lnevery surgical case. This fact is especially true in spinal su
`with additional anterior or posterior nstrvmentatlon to augment stability. Use of this produrx wnhout a bone graft may not be successful.
`No spinal im lent can withstand body loads without the support of bone. In this event. bending. loosening, disassembty and/or breakage of the
`device(s) WI eventually occur.
`Preoperative and operating procalurus, including lrriowledge of surgical techniques, proper selection and placement of the implant and good
`reduction are important considerations ui die success of surgery. Inslalketion and positional adiustrnent of implants must only be done with special
`equipment and tnstrumems specific to these devices. Th must not be used with ot_her instrumentation unless specifically recommended by
`Medtronlc Sofamor Danek because the combination with o
`r instrumentation my be incompatible, and may not be guaranteed.
`
`
`
`
`__._._._._....._...
`
`'§.'i3=’§T~"-8!°.°°>|saw.1-.w.~.-+e=s=
`
`on
`determined by
`e rupture of the bolt. The screws should be tiglrtone and roken off in situ after the final placement of the device. The br
`is
`The assembluftgarts have in situ length adjustment Self-brualdng pl
`s are rovided for plate fixation to the cyinders. The final torque sold
`rs
`part should not remain in the peuent. Never reuse an Intemal fixation device under any uvcumstances. Even when a removed device ap
`undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Dam of the thread will reduce the slab try of
`the instrumentation. Further, the roper selection and COTTIOIBDCO of the patient will greath affect the res
`ls. Patients who smoke have been shown
`to have an increased incidence o non-unions. Those patients should.be advised of this fact and warned of this consequence. Obese. malnourished,
`and/or alcohol abuse patients are also poor candidates for some fusion.
`
`inddcal center cages of various le
`DESCRIFTION:Tha VERTE-STACK‘? DEVICE CONSISTS OF PEEK (POLYFIHERETHERKETONE) he_rn'
`CE
`e assembled VERTE-STACK" D
`and diameters. as well as herni
`rndncal add on cages of various lengths, diameters and an ulabon.
`COMPONENTS CAN BE RIGIIJLY LOC
`O INTO AVARlEI'Y OF CONFIGURATIONS, WITH EACH CONSTRUCT BEI E TAILOR-MADE FOR THE
`CONSISTS OF THREE COMPON
`S ONE HOLLO PEEK CENTER CAGE, AND TWO HOLL W ADO—ON CAGESh THE VERTE—STACK"'
`|NDlVlDUAl. CASE. THE VERTE-STACK" SPINAL SYSTEM IMPLANT COMPONENTS ARE MADE OF MEDICAL GRADE PEEK LT1 DESCRIBED
`BY ASTM STANDARD F1579. THE TANTALUM MARKER USED FOR THIS PRODUCT IS MADE TO THE VOLUNTARY STANDARD OF ASTM
`F560. MEDTRDNIC SOFAMOR DANEK EXPRESSLY WARRANTS THAT THESE DEVICES ARE FABRICATED FROM THE FOREGOING MATERIAL
`SPECIFICATIONS. NO OTHER WARRANTIES, EXPRESS OR IMPLIED. ARE MADE. IMPLIED WARRANTIES OF MERCHANTABILITV AND FITNESS
`FOR A PARTICULAR PURPOSE OR USE ARE SPECIHCALLY EXCLUDED.
`
`fem
`
`I
`
`e following titanium Medtronlc solamor Danek spinal systems or their successors must be used with the VERTESTA l("‘ spinal system.
`Lbs VERTE-STACK" spinal system must be used with additional anterior endlor posterior spinal lnsbumentatlori to augment xtablllty. one of
`Anterior
`Posterior
`/
`stem
`ZPLATE ll" Anterior Fixation
`I
`DYNALOK CLASSIC“ Spinal System
`/
`Laurain De Wald Anterior Fixation
`./
`J
`TSRH’ Spinal gysiem
`/
`/
`CD HORIZON’ Spinal System
`Do not use implant components from any other manufacturer with VERTE~STACK“‘ S inal System components. Stainless steel and PEK implants
`reuse
`fie not cotmpaliblo with each other. They must not be used together in a construct.
`with all orthopedic implants, in no case may the implants
`IlIDlCAl1DNS:‘Ihe VERTE-STACK" Spinal %stem is a Vertebral body replacement device intended for use in the thoracolumbar spine (l1—l.5) to
`replace a collapsed, damaged, or unstable vertebral bo
`due to tumor ortrauma (l.e., fracture). The VERTE~STACK“‘ Spinal System is to be used
`with su
`lemenfal fixation. Specrfiral
`, the l_IERTE~ST K“ device is to be used with the Medtronic Sofemor Danek ZPLATE ll‘ Anterior fixation
`System,
`rtanium DYNALDK CLASS! f“ 5 mal system. Lauraln Dewald Anterior Fixation
`stern, Trtariuiri TSRH' Spiral system, Titanium CD
`HORIZON‘ Spiral system or the Titanium DLH‘ spinal Q/stem. Additionally, the VEITTEST GK" device is intended to be used with bone graft.
`CONTRAINDICATIOIIS:
`The VERTE-STACK" device is not intended for cervical nor posterior surgical Implantation.
`Contraindications include, btrt are not imited to:
`infection, local to the operative site.
`Signs of local inflammation.
`Fever or luulrocytosis.
`Morbid obesity.
`Pregnancy.
`Mental flhess.
`
`

`
`For product availability, labeling limitations, and/or more information on any MEDTRONIC SOFAMOR DANEK USA, INC.
`products, contact your MEDTRONIC SOFAMOR DAN EK USA, INC. Sales Associate,
`or call MEDTRONIC SOFAMOR DAN EK USA, INC. Customer Service toll free: 800-933-2635.
`
`% Medtronic
`
`SOFAMOR DAI\lEK
`
`MEDTRONIC SOFAMOR DANEK USA, INC.
`
`1800 Pyramid Place
`(901) 396-3133
`Customer Service:
`
`Memphis, TN 38132
`(800) 876-3133
`(800) 933-2635
`
`www.sofamordanek.com
`
`©2002 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. Patents Pending.
`
`LITVSTKST2