Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22657 Page 1 of
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`EXHIBIT 14
`
`
`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
`
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22658 Page 2 of
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`FEATURES
`
`• Oanial/Caudal blades open
`independently
`
`• DepthControl alows blades to
`raise and lower +/ • 5n,m ( 1 Com
`total variabiltty)
`
`• Leverroe·• mechanics ensure the
`blades stay on a parallel plane as
`the toe up to 15°
`
`• CounterFlex mechanism prevents
`aperture narrowing
`
`• Fbbust implanVinserler interface
`with one step ETA' (engage, twist,
`attach) loadng
`
`• Forth blade features ar1iculatlon and
`DepthControl"'
`
`•
`
`• IITl)lants designed lo prorrote
`sagittal balance
`
`• Intelligent instrumentation featuring
`Stealth Coating•w lo prevent glare,
`~haTexture'" handles, and
`rrodular instruments with depth
`and orientation indicators
`
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`
`THORACOLUMBAR I Suroical Te8hn!QJ e G~ioe
`
`ATEC LLIF000167294
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22659 Page 3 of
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`
`: Battalion La:cm1 - Lumbar Spacer Sys~elTl
`.
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`
`PREFACE
`The Battalion Lateral Spacer System has been
`designed with surgeon utilization and patient
`outcomes in mind. The System feahres a three blade
`retractor system combined with broad disc prep and
`implant offerings.
`
`The Battalion LLIF Disc Prep sets feature both
`standard (straight) instruments, as well as offset
`(cranial/cauda0 options for surgeons to access each
`level of the lumbar spine.
`·
`
`Alphatec Spine has created' a three blade,
`hand-held Squadron'~ Retractor Lateral Access
`System and added features such as independent
`cranial/caudal blade movement, 0-15 degrees of
`Le\lelToe'", the ability to replace blades in situ, and to
`raise and bwer blades 10mm in situ.
`
`Implants are designed to be used in the lumbar disc
`spaces as interbodies.
`
`CONTENTS
`
`Preoperative Planning
`
`..... .. .. ..... ........... .......... ., ........................... ...... ,. ........... ............................ .. 3
`
`Patient Positioning
`
`................................................ .. .................................................................. 3
`
`Access Identification and Initial Incision
`
`······· .. ··· ........................................ ................................. 4
`
`Retroperitoneal Access
`
`........... ......................... ......... ...... .............. .......................... ....... .. ......... 4
`
`Retroperitoneal Approach
`
`............. .................... ............ .................... ......... ............................... 5
`
`Traversing the Psoas
`
`.......... ..... .................. ....................................... ...................................... 6 11
`
`Disc Space Access -
`
`...... ............................................................... ... .................................... 12 20
`
`Oise Preparation -
`
`........................... ................ ............................... ..... ....................................... 21
`
`Implant Sizing-
`
`............................................. ................... ................... ................... ... .. ...... .... 22 23
`
`Implant Insertion and Positioning
`
`..... ...... .. ...................................... .. .. ....... .................... ....... . 24-25
`
`Supplemental Fixation
`
`.......................... ....... .............................. .................. ............ ... .. ............. 26
`
`Closure
`
`...... .................................................................................... ............... ............................ 26
`
`Implant Removal
`
`..................................... ............. .... .............. ................... .... ......... ................... 27
`
`IFU .......... ........................................................................... ................ .............. .. ............... ............. 28
`
`_. - -- - - - - - -- - - - - - - - - - - - - - - - - - -- - - - - - wwwak:i1atecs>Jnecom
`
`ATEC_LLIF0001 67295
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22660 Page 4 of
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`PREOPERATIVE PLANNING
`
`The Squadron'" 'Retractor Lateral Access
`System has been designed to allow for
`the use of neuromonitoring based on
`the surgeon's discretion and may be
`used with many commercially available
`neuromonitoring systems,
`
`PATIENT POSrrlONING
`
`Ensure that the surgical table is reversed
`before the patient is positioned so that
`fluoroscopy can be used. Place the
`patient in a lateral decubitus position on
`a bendable (breaking) table so that the
`patient's greater trochanter sits directly
`above the table break.
`
`LUMBAR ACCESS
`Following the patient's placement on the
`table, the patient will be secured with
`surgical tape .. If the levels being accessed
`are the in the lumbar spine, 1he patient
`should be taped at the following locations:
`
`Below the iliac crest
`
`Over the thoracic region
`
`From the iliac crest to the knee, taking
`care to pad the perennial nerve (tape
`will then be seamoo to the table}
`'
`From under the table on the ipsiateral
`sde, to the knee, past the ankle ard then
`to the contralateral side under the table
`
`VERIFYING APPROPRIATE
`PLACEMENT
`Use fluoroscopy to verify the location
`of the levels to be accessed. Once
`the patient is properly secured, adjust
`the table so that the C-arm is able to
`provide a true NP image when at 0
`degrees, and a true lateral position at
`OCJ, degrees.
`
`Adjust the table to the appropriate
`position depending on the level or
`levels being accessed.
`
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`ATEC LLIF000167296
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22661 Page 5 of
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`
`, Battalion Latera - LL,rnbar Spacer System
`
`-
`
`-
`
`.... .; · ,· ~~
`
`· ACCESS IDENTIFICATION AND INITIAL INCISION
`
`- - - -
`
`.
`
`Rrst, localize the operative level using
`true lateral fluoroscopy. With ink, make
`a mark en the skin to serve as the
`location for the initial skin incision at
`the operative level.
`
`NOTE: If utilizing a two incision
`techrique for the transpsoas
`approach , another mark
`will be made on the skin
`posterolaterally between the
`ilium and the rib cage.
`
`RETROPERITONEAL ACCESS
`
`Either through the lateral or
`posterotateral incision, dissect
`subcutaneous tissue layers by
`alternating with blunt scissors
`and finger dissection until the
`retroperitoneal space is reached.
`
`Once inside the retroperitoneal space,
`carefully sweep the peritoneum
`anteriorly.
`
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`ATEC LLIF000167297
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22662 Page 6 of
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`
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`RETROPERITONEAL ACCESS
`
`Once the peritoneum has been swept
`anteriorly, use the index finger to
`palpate the psoas muscle .
`
`R ETROPERITONEAL APPROACH
`
`Create a safe pathway between the
`abdominal wall and t he psoas muscle
`by using the index finger to sweep
`up to the Inside of the abdominal wall
`directly underneath the lateral skin
`incision.
`
`Place the Universal Clip onto exposed
`silver ring at the proximal end of the
`Dilator and connect to the appropriate
`neuromonitoring platform.
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`ATEC LLIF000167298
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`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22663 Page 7 of
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`. -
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`. · Battalion Lateral - Lumbar Spacer System
`.
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`
`RETROPERITONEAL APPROACH
`
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`Once a safe pathway has been
`created, insert the Initial Dilator into the
`space. Use the index finger to guide
`the Dilator to the psoas muscle.
`
`Once the Initial Dilator has reached the
`psoas muscle, verify the placement
`with lateral fluoroscopy.
`
`TRAVERSING THE PSOAS
`
`Carefully split the musde fibers of the
`psoas by advancing the mator in a
`clockwise to counter-clockwise motion.
`Neuromonitoring may be used to
`detect the location and proximity of the
`nerves as the psoas is traversed. EMG
`or MMG are always recommended to
`monitor motor function. Additionally,
`SSEPs may be used to monitor sensory
`nerves throughout t he procedure.
`
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`ATEC LLIF0001 67299
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`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22664 Page 8 of
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`
`.·
`
`·
`
`Surgical ·1ec1~1r11q~.e :: __ -tJi:ie
`
`' •
`
`; TRAVE,RSING THE PSOAS
`
`Once the 'initial Dilator has been placed
`on the disc space, confimi its position
`with lateral fluoroscopy .
`
`Adjust the Dilator's position so it is
`flush with the disc space and confirm
`with AP fluoroscopy. Once the Dilator's
`appropriate position is confirmed,
`introduce the K--wire through the Dilator
`halfway into the disc space.
`
`llJI
`
`Take note of the Dilator depth and add
`10mm to determine the desired blade
`length. Blade lengths are laser marked
`on the outside of each Retractor blade.
`
`~ • • • •
`' • • I • ..
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`ATEC LLIF000167300
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`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22665 Page 9 of
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`
`... ,
`'. Battalion La:era, - Lumba' Soacer System
`J ;:.~~ jJ, _,,__/
`.
`~ ~ ~ '
`
`Remove the neuromonitoring Universal
`Clip and attach to the Secondary
`Dilator .
`
`• TRAVERSING THE PSOAS
`• •
`•
`•
`•
`• • •
`• • •
`
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`Introduce the Secondary Dilator over
`the Initial Dilator using a clockwise,
`counter-clockwise motion. Advance the
`Second Dilator until it is flush with the
`disc space .
`
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`ATEC LLIF000167301
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22666 Page 10 of
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`
`; TRI\VERSING THE PSOAS
`
`Attach the Arms to the Squadron ..
`Retractor by depressing the gold
`button on the body of the Arm, and
`inserting t,he handle INith the Trigger
`Locks to the outside of the Retractor .
`
`Load appropriately sized blades onto
`the Retractor directly in front of the
`Blade Release Levers. An audible click
`confirms each blade is fully inserted
`and locked into place.
`
`-
`
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`
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`
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`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22667 Page 11 of
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`
`•' Battalion Lateral -- Lu1"'lbor Sooccr Systcrr
`
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`J • TPAVERSfNG THE PSOAS
`
`►
`
`IBlades may be replaced/removed by
`depressing the Blade Release Levers
`and pulling the blades away from the
`patient.
`
`The Retractor is then introduced into
`the space over the Second Dilator
`using a clockwise, counter-clockwise
`motion until the Retractor is flush with
`the disc space. Confirm location of the
`Retractor with AP Fluoroscopy.
`
`- - - - - - - - - - -- - - - -- --
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`ATEC LLIF000167303
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22668 Page 12 of
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`• TRAVERSING THE PSOAS
`
`The Retractor blade heights can
`be adjusted by turning the gold
`DepthControl'• screws on the Retractor
`blades. Turning the screw clockwise
`will lower the blade, while turning the
`screw counter-clockwise will cause the
`Retractor blade to rise.
`
`Toe the blade by turning the gold
`LevelToe'" screws in the direction
`indicated on the dial. The Retractor will
`allow for 15 degrees of toe per blade.
`
`NOTE! Do not torque beyond the
`physical stop that is reached at
`15 degrees. Over torquing may
`damage the Toe Driver.
`
`aA1P11atecSp/11B' - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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`ATEC LLIF000167304
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22669 Page 13 of
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`
`1 Battalion Lateral - Lumbar Spacer Systen 1
`
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`DISC SPACE ACCESS
`
`Secure the Table Fixation Arm Bed
`Rail Clamp to the surgical t able on the
`patient's dorsal side near the armpit
`and rotate the lever clockwise until
`firmly affixed .
`
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`Attach the Table Fixation Arm post to
`the Bed Rail Clamp and adjust to the
`preferred height. The opposite end a
`the Arm will then be attached to the
`Retractor.
`
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`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22670 Page 14 of
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`
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`Surgical Techn que Guide
`
`DISC SPACE ACCESS
`
`The Table Fixation Arm can be attached to
`the Retractor in two locations:
`
`Position 1 holds the post erior blade
`st ationary while the left and right
`blades are free to traverse when the
`NP Dial is rotated.
`
`Posftlon 2 holds the left and right
`blades stationary while the posterior
`blade is free to traverse wlien the NP
`Dial is rot ated.
`
`Attach the Arm t o the Retract or by
`depressing the gold button at the end
`of the Arm and inserting it onto the
`desired location.
`
`Position 1
`
`A/P Dial
`
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`ATEC LLIF0001 67306
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22671 Page 15 of
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`
`"
`
`' ,. Battalion Lateral - Lumbar Spacer System
`·----
`DISC SPACE ACCESS
`
`,/
`
`'·
`
`Once engaged, the Retractor and Arm
`can be adjusted until the appropriate
`angle is reached.
`
`Once in place, use the Wrench t o
`final tighten the Arm engagement and
`secure the Retractor.
`
`NOTE: Slight downward force while
`opening tl1e Retractor is
`recommended to ensure blade
`depth is maintained.
`
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`ATEC LLIF000167307
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`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22672 Page 16 of
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`DISC SPACE ACCESS
`
`Blades may be expanded
`independently cranially and caudally
`by fully depressing the Trigger Locks
`attached to the handles of the
`Retractor body.
`
`To dose the Retractor, push forward on
`the Single-Step Thumb Release, and
`move the Retractor Arm outwards.
`
`ATEC LLIF000167308
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22673 Page 17 of
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`
`.
`\ _B~tt~lion Lateral -- Lur1bar Spacer System
`
`• -·
`
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`
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`
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`
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`
`-- - -
`
`DISC SPACE ACCESS
`
`Blade toe may be increased by using
`the Blade Toe Driver at the LevelToe'"
`articulation points.
`
`'NOTE: Care should be taken to avoid
`compromising the neural
`elements behind the center
`blade.
`
`Blades may also be raised or lowered
`using the Blade Toe Driver at the
`Depth ControlM articulation points to
`accommodate patient anatomy.
`
`• • • •
`
`If a different length of blade is desired,
`blades may be changed by depressing
`the gold Blade Release Levers and
`removing the blade.
`
`+1 5°
`
`10mm
`
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`ATEC LLIF000167309
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`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22674 Page 18 of
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`
`. ·
`
`.
`
`Surgical TechniqL.e Guide
`
`DISC SPACE ACCESS
`
`Squadron™ Retractor
`
`LaL, al · cc ·ss S:,1st9rn
`
`Gold markings denote articulation points.
`
`-
`
`AIP Dial: oontrols anterior/ posterior blade pos~iort
`• Position 1: advance anterior blades
`• Position 2: ret ract posterior blades
`
`Handle attachment point
`
`Single-Step Thumb Release:
`l Push lever towards blades to
`close Retractor
`
`Single-Step Thumb Release
`
`LeveIToe'" articulation point
`
`Handle
`attachment
`point
`
`levelioe'" Articulation Points:
`Increase toe with Toe Driver
`by up to 15 degrees
`
`Table mounting Position 2
`
`Table mounting Position 1
`
`Blade Release Levers
`
`ATEC LLIF000167310
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22675 Page 19 of
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`
`•' Battalion Lateral - Lumbar Spacer System
`
`•_ ,,
`
`DISC SPACE ACCESS
`
`Remove the Dilators, taking care to
`keep the K-wire in place.
`
`The Light Cable and the Light Source
`Connector are then placed halfway
`down the right or left blade and are
`bent away from the surgical path.
`Ooing so helps ensure unobstructed
`vjsibility into the disc space. Light
`Source Connectors are designed to be
`single use only.
`
`Connect the base of the reusable cable
`to the light source provided by the
`hospital. Multiple manufacturer specific
`adaptors are provided in the surgical
`set.
`
`'In preparation to place the Shim,
`verify the appropriate position of the
`Retractor with A/P fluoroscopy.
`
`Visuaffy verify that tissue or neural
`structures are not compromised by the
`Retractor blades during retraction. Use
`a Ball Tip Probe to test surrounding
`tissue. Take care not to touch the
`Probe tip lo the blade as the Retractor
`is conductive.
`
`Use a Penfield to move any residual
`tissue behind the Retractor blades.
`
`•
`
`1,vvvwalphatecspine.com
`
`ATEC LLIF000167311
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22676 Page 20 of
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`
`..
`
`Surgical Tech111que Guide
`
`DISC SPACE ACCESS
`
`Load the lntradlscal Shim onto the
`Shim Inserter. Shims are designed to
`be single use only.
`
`7
`
`L
`
`1.7mm
`
`Finger loop for -
`enhanced control
`
`+----Impaction s1.1face
`
`-Gold button engages/
`d isengages Shim
`
`To stabilize the Retractor, place the
`lntradiscal Shim through the center
`blade of the Retractor ensuring that
`the tabs on either side of the Inserter
`engage into the tracks on the inside
`of the blade, Advance the Shim until it
`engages into the disc space and locks
`at the bottom of the blade. Press the
`gold button at the proximal end of the
`Inserter to disengage the Shim.
`
`Once the Shim has been placed,
`remove the K-wire.
`
`Confirm under AP and lateral
`fluoroscopy that the Shim is within the
`disc space.
`
`ATEC LLIF000167312
`
`

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`· Battalion Lateral - Lumbar Soacer System
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`DISC SPACE ACCESS
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`Expand the right and/or left blade
`to expose the disc space and gain
`optimal access for t he procedure.
`
`Retract the psoas anterior to visualize
`the disc space by rotating the gold NP
`Dial. The Blade Toe Driver may be used
`for additional torque.
`
`Localize the All and place the 4th
`blade as needed. The 4th blade should
`be placed to the desired depth and
`secured through the blade eyelets
`with the 4th Blade Attachment or the
`Attachment Cross Bar
`
`NOTE: Limit expansion of the Retractor
`to the disc space as over~
`expanding the retraction may
`cause trauma to the psoas.
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`Proximal coaar locks
`blade angLllation
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`-
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`oomm
`knLl'led
`hardle
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`Centerline ridge locks
`4th blade depth
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`80mm
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`-Blade is 1mm thick
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`- - - - - - - - - - - - - - - - - - - - www~,atecepne com
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`ATEC LLIF0001 67313
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`

`

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`Surgica;Tecnnique G01cle
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`DISC PREPARATION
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`Perform an annulotomy to
`accommodate the selected implant
`width (anterior to posterior) with the
`Annulotomy Knife. A Cobb Elevator is
`then passed through the disc space to
`release the contralateral annulus.
`
`Utilize additional Disc Preparation
`Instrumentation such as Pituitaries,
`Endplate Scrapers, Kerrisons, Chisels,
`Curettes and Broaches to thoroughly
`prepare the disc space and endplates.
`
`Instruments are available in straight,
`angled, and offset configurations.
`lnserters are available in straight,
`cranial/caudal and medial/lateral
`orientations.
`
`7
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`12
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`Straight o•, Angled 7°, Offset 12°
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`NOTE: Oise Preparation Instruments
`feature depth and orientation
`indicators.
`
`aAJpllpte_cSplne· ~ - - - - - - - - - - -
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`ATEC LLIF000167314
`
`

`

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`; Battalion Lateral - Lumbar Spacer System
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`IMPLANT SIZING
`
`Introduce a Primary Distractor to
`distract the disc space and estimate
`the appropriate implant heig1ht .
`
`Attach the Handle to the Trial by pulling
`back on the silver collar on the Handle
`and Inserting the Distractor until the
`indentation is fully seated within the
`Handle. Relea:ie the collar to lock the
`Distractor. Confirm locking by pulling
`on the Distractor .
`
`lhe Distractor Handle may be removed
`once in place to facilitate fluoroscopy .
`Increase the Distractor size until the
`appropriate implant height is reached.
`
`Additional trialing may be performed
`with the PEEK trials that attach to the
`end of the Implant Inserter.
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`ATEC LLIF0001 67315
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`

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`Surg,::::<:11 Teel 1n q_1c Gu1oe
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`IMPLANT SIZING
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`Attach the Trial to the Battalion WF
`Inserter by aligning the tangs of the
`Inserter INith the Trial, depressing the
`gold button, and rotating the Inserter
`180 degrees.
`
`Using A/P fluoroscopy, impact the Trial
`into the disc space. Confirm correct
`size and width for the patient anatomy.
`The Battalion LLIF Inserter Handle may
`be removed to facilitate fluoroscopic
`imaging.
`
`aAJpl}atecSpfnB' - - - - - - - - - - - - - - - - - - - - - - - - - - -
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`ATEC LLIF000167316
`
`

`

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`-- -------
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`-- BaHalionTaf~:rilr _-:_ l ln oi:y Spacer Systo11-1 -
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`IMPLANT INSERTION
`
`Choose the appropriate implant by
`width, length, !ordosis, and height as
`determined by trialing .
`
`Attach the implant to the Inserter by
`lining up the implant's lateral notches
`with the tangs of the Battalion UUF
`Inserter. Depress the gold button and
`rotate the Inserter Handle clockwise
`180 degrees to lock the in)plant on to
`the Inserter .
`
`NOTE: Ensure the Inserter is in
`the unlocked orientation by
`checking t/-e laser marked
`indicators at the base of the
`Inserter shaft.
`
`Prepack the implant with the
`appropriate biologics, allograft or
`autograft.
`
`Optional Implant Slides may be
`used to aid angled approaches to
`the spine.
`
`r Slap hammer attachment
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`Avallable in:
`• Short (220mm)
`• Long (305mm)
`• Normal (12.5mm)
`• Wide ◄17mm)
`
`,Flexible ln order to Adjust to anatomy
`
`1mmtrack:
`• Enables exact implant
`placement
`• Prevents Implant friction
`during Implantation
`
`- -~- - - - - -~ - - - -- - - - - - - - -- -- - - - - -- - --
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`www.i3lp!,atecsp-,e.com
`
`ATEC LLIF000167317
`
`

`

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`Surgical Techrnquo Gu1oc
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`IMPLANT INSERTION
`
`Graft Containment Slides may be
`attached to the proximal end of the
`Inserter and advanced until they cover
`the implant. As the implant is impacted,
`the Slides will not advance into the disc
`space due to the resistance provided
`by the depth stop.
`
`Confirm appropriate implant placement
`by using A/P fluoroscopy,
`
`The Inserter is disengaged by
`depressing the gold button and rotating
`the Handle counter clockwise. If Graft
`Containment Slides are connected to
`the Inserter, they will remain connected
`as the Inserter is withdrawn from the
`patient.
`
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`leading edge
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`f Low profile
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`Proximal end engages 1
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`Inserter shaft
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`ATEC LLIF000167318
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22683 Page 27 of
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`~: Battalion Li.Hcrar -- Lurrba· Spc:.ClY Sys:orT
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`SUPPLEMENTAL FIXATION
`
`The Battalion LLIF system is indicated
`for use with supplemental focation
`including the ILllCO- MIS system,
`Arsenal"' Spinal Fixation System,
`ILLICo:t FS System or the Bridgepoint4t
`Spinous Process Plate.
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`CLOSURE
`
`Close the wound using standard
`surgical techniques.
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`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - www.a.pt"atecspine.con,
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`ATEC LLIF000167319
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-14 Filed 01/18/20 PageID.22684 Page 28 of
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`Surgical Technique Guide
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`IMPLANT REMOVAL
`
`If implant removal is necessary,
`access to the implantation site can be
`achieved in a similar fashion as the
`original access. Once the 1implant is
`exposed, reattach the Battalion LLIF
`Inserter and gently remove the implant.
`The Slap Hammer may be attached to
`the Inserter if needed.
`
`If the implant is difficult to _remove, the
`Implant Removal Tool can be used.
`
`Align the midline hole of the implant
`with the Removal Tool and rotate
`the Removal Tool clockwise until the
`implant is firmly attached.
`
`Remove the implant from the disc
`space. A Slap Hammer may be
`attached to the proximal portion of
`the Removal Tool to ad removal. The
`Removal Tool may also be used on
`broken implants by threading through
`the center hole in each individual
`portion of t he implant.
`
`A/pllatecSpfnB· - - - - - - -- - - - - - - - - - - - - - - - - - - - - -
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`ATEC LLIF000167320
`
`

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`.. Battalion ~atom, - Lu11l)a1· S:Jacur Sys:e111
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`it INST'AUCTIONS FOA use
`t Battalion~ Universal Spacer System
`
`5. Implants are single use devices. Do nol reuse. W hile an implant may
`appear undamaged,. It may have smal defects or internal stress patterns
`that could lead tofatigue failure. In adcition, the,rernovedimplant has not
`been designed or vatidated for the decontamination of miaoorganlsms.
`Reuse of this product could lead to cross-Infection and/or material
`degradation as a result of the decontamination process.
`6. These implants are used only to provide interrel f1Xation, in conjunction
`with graft and supplemental fixation, during the bone fusion process.
`A successful result rmy not be achieved in every instance. The benefit
`of spinal fusions utiHzlng any 1/eltebral body replacement has not been
`adequately established in patients with stable spines.
`7. Po1ential risks identified with the use a these fusion devices, which
`may require additional surgery., include device oomponent failure, loss
`of fixation, pseudoarthrosis Q.e. non-union), fracture of the vertebra,
`neurological injury, and/or vascular or visceral injury.
`a Risk factors that may affect sucx:essful SUl!Jical outcomes include: alcohol
`abuse, obesity, patients with poor bone, muscle and/or nerve quality.
`Patients who use tobacco a nicotine produ<;ts should be advised of
`the consequences lhat an Increased incideooe of non-union has been
`reported with patients who use tobacx:o a nicotine products.
`
`PRECAUTIONS:
`1. lmplantalion should be perf01TT1ed only by experienced spinal surgeons
`with specific training in the used this device because this is a technicatty
`demanding procedura presenting a risk of senous injury to the patient.
`2. These implants have not been evaluated for safety and compatibitity in the
`Magnetic Resonance (MR) environment. It has not been tested for healing
`a migration in lhe MR environment. The safety d the Battalion System in
`the MR environment is unlmown. Scanning a patient who has this device
`may result in patient injury.
`3, Installation and positional adjustment of implants must only be done
`wilh special equipment and instruments specific to these devices.
`They must not be used with other instrumentation unless specifically
`recommended by Alphatec Spine Inc., because the combination with
`other instrumentation may be incompatible.
`4. Based on dynamic testing results, the physician/surgeon should consider
`the levels of implantation, patient weight, patient activity level, other
`patient conditions, etc., which may impact the performance of this system
`5. Patients with previous spinal surgery at the leve~s) to be treated may have
`different clinical outcomes compared to those without previous surgery.
`
`POSSIBLE ADVERSE EFFECTS:
`Possible adverse effects include:
`1. Initial or delayed loosening, bending, dislocation and/or breakage of
`device components.
`2. Physiological reaction to implant devices due to foraign body intolerance
`including inflammation, local t issue maction, serorm, and possible tumor
`formation.
`3. Loss of desired spinal curvature, spinal correction and/or a gain or loss in
`height.
`4. Infection and/or hem01thaglng.
`5. Non-union and/or pseudarthrosls.
`6. Neurologlcal disorder, pain and/or abnormal sensations caused by
`improper placement of the device, and/or inslluments.
`7. Subsidence of the device into the vertebral body.
`a. Revision surgery.
`9. Death.
`
`• GENERAL INFORMATION:
`,~ The Battalion Universal Spacer System (Battalion System) is an intervertebral
`body fusion device with Implants of various lengths, widths, heights, and
`degrees of lordosis to acx:ommodate lncividual patient amtomy. The
`h implants are manufactued from PEEK Optima LT1 with/without tttanium
`, coaled endplates and tantalum mar1<ers. All materials are surgical grade
`I>:\ confom,ing lo ASlM F2026 (PEEK), ASTM F1580 (titanium coamg), and
`if ASTM F560 (tan1alum).
`! Use with supplemental fixation systems fromAlphatecSpine such as: Zodiac
`e. Polyaxial Spinal Fixation System, Arsenal Spinal F"ixation System, ltico MIS
`7 Posterior Fixation System, llllco FS Facet Fixation System, and Bridgef'olnt
`~ Spinous Process Rxation System.
`
`~ INDICATIONS:
`The Battalion System is Indicated for spinal fusion prooedures In skeletalty
`' mature patients at one or two contiguous levels in Iha thoracolumbar spine.
`
`~ Thoracic: Tt.1'2 to T11+T12, or at the thoraoolumb~ junction (T12-l1),
`, following discectomy for the traatment of a symptomatic degenerative
`, dsc disease (DOD), including thoracic disc herniation (myelopathy and/or
`~ radiculopathy with or without axial pain). The lateral approach is limited to
`7 levels T5-6 to T11-T12.
`l Lumbar: l1-L2 to LS--S 1, fo, the treatment of degenerative disc disease
`t (DOD) with 141 to Grade I spondylolisthesis or ratrolisthesis at. the involved
`level(sl, DOD is defined as back pain of dlscogenic origin with degeneration
`I of the disc confinned by history and radiographic studies.
`
`I The Battalion System is intended for use ai patients who have had at least
`six months of non-operative treatment. The Battaion System is intended
`I for use with autogratt or allogratt (eg. Alogenlc bone graft composed of
`cancellous and/or corticocanceUous booe graft) and supplemental fixation
`1 s~tems ttet are cleared by FDA for use in the thoracic and lumbar spine.
`
`1 CONTRAINDICATIONS:
`The Battaion System is contraindicated for:
`1. Patients with bone rasorption related disease(e.g. osteopenial, bone and.I
`or joint disease, or defident soft tissue at the wound site.
`2. Patients with infection, inftammation, fever, h.mors, elevated wtite blood
`count, obesity, pregnancy. mental ilness and aher medical conditions,
`wtic:h would pnlhibit beneficial sugical outcome.
`3. Patients with allergy or intolerance to PEEK, titanium, a tanta.kJm
`4. Patients resistant to following post-operative restrictions on movement
`especially in athletic and occupational activities.
`5. Patients with prior fusion at the level(s) to be treated.
`6. Spinal surgery cases that do not requJra bone grafting and/or spiml
`fusion.
`7. Reuse or multiple uses of the implant.
`
`WARNINGS:
`1. The implants and S