Case 3:18-cv-00347-CAB-MDD Document 253-12 Filed 01/18/20 PageID.22609 Page 1 of
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`EXHIBIT 12
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`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
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`ATEC LLIF000167276
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`PREFACE
`
`Lateral lnterbody System has been designed with
`surgeon utilization and patient outcomes in mind.
`The System features broad disc prep and implant
`offerings.
`
`Lateral lnterbody System features both standard
`(straight) and offset (cranial/caudal) disc prep
`options for surgeons to access each level of the
`lumbar spine.
`
`The spine may be accessed using the ATEC Squadron®
`Retractor System. ATEC Squadron three-blade
`Retractor System features independent cranial/caudal
`blade movement, 0-5 degrees of parallel auto toe,
`ability to replace blades in-situ and the ability to raise
`and lower blades in-situ.
`
`ATEC's lateral system is designed to be used with
`both ldentiTi and Transcend interbody spacers in the
`thoracic and lumbar spine.
`
`CONTENTS
`Patient Positioning - II .
`Level Identification and Init ial Incision - fJ
`Retroperitoneal Access - IJ .... . .... .
`Retroperitoneal Approach - D .............. ..
`Traversing the Psoas - 1J ......................... ..
`Disc Space Access - Ill ............................. ..
`Disc Prepa1·at ion -D ...... .. ..... . ..... ........ ....................
`.. ......... ..
`.. ........... .
`Hyperlmdodic Applications - IJ ................. .............. ....
`Implant Sizing - IJ ......................................... .................................................. ....... .
`Implant Insertion and Posit ioning - £m
`Supplemental Fixat ion - a,
`Closure -aJ
`Implant Removal - £!I ..... ............ .......... .
`IFU Excerpt
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`.3
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`..... 4
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`. ... . 4
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`.. .S
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`.. .... 6-7
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`. .. 8-10
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`.11
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`.11
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`. ...... ....... 12
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`.. .. 13
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`.. .. 14
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`...... .. .. 14
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`. ........ 14
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`.. 15
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`a
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`ATEC_LLIF000167277
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`a PATIENT POSITIONING
`
`Confirm 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, secure the patient with surgical tape.
`If the levels being accessed are in the lumbar
`spine, the patient should be taped at the
`following locations:
`
`1. Below the iliac crest.
`
`2. Over the thoracic region.
`
`3. From the iliac crest to the knee, taking
`care to pad the peroneal nerve.
`
`4. From under the table on the ipsilateral side,
`to the knee, past the ankle and 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
`A/P image when at O degrees, and a true
`lateral position at 90 degrees.
`
`• Adjust the table to the appropriate
`position depending on the level or levels
`being accessed.
`
`a
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`ATEC LLIF000167278
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`Lateral lnterbody Fusion - Surgical Technique Guide
`fJ LEVEL IDENTIFICATION ANO INITIAL INCISION
`
`• Localize the level to be accessed using
`true lateral fluoroscopy. With ink,
`make a mark on the skin to serve as
`the location for the initial skin incision
`at the operative level.
`
`IJ RETROPERITONEAL ACCESS
`
`• Through the incision, dissect
`subcutaneous tissue layers by
`alternating with blunt scissors and
`finger dissection until you are in the
`retroperitoneal space.
`
`• Once inside the retroperitoneal space,
`carefully sweep the peritoneum
`anteriorly. Once the peritoneum has
`been swept anteriorly, use the index
`finger to palpate the psoas muscle.
`
`ATEC LLIFOOO167279
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`a RETRO PERITONEAL APPROACH
`
`• Create a pathway between the
`abdominal wall and the psoas muscle
`by using the index finger to sweep up
`to the inside of the abdominal wall
`directly underneath the lateral skin
`incision.
`
`• Once a pathway has been created,
`insert the Initial Dilator into the space,
`using the index finger to guide it to
`the surface of the psoas muscle. Once
`the Initial Dilator has reached the
`psoas muscle, verify the placement
`with lateral fluoroscopy.
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`ATEC LLIFOOO16728O
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`a TRAVERSING THE PSOAS
`
`• Carefully split the muscle fibers
`of the psoas muscle by advancing
`the Initial Dilator in a clockwise to
`counterclockwise motion.
`
`• Once the Initial Dilator has reached
`the lateral surface of the disc
`space, fluoroscopy should be used
`to confirm its position. Adjust the
`Dilator's position so it is flush with
`the disc space, parallel to it, and in
`the preferred position anterior to
`posterior.
`
`a
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`ATEC LLIF000167281
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`Lateral lnterbody Fusion - Surgical Technique Guide
`D TRAVERSING THE PSOAS
`
`• Once the Dilator's appropriate
`position is confirmed, introduce the
`K-wire through the Initial Dilator
`halfway into the disc space.
`
`•
`
`Introduce the Secondary Dilator
`over the Dilator using a clockwise to
`counterclockwise motion until the
`Second Dilator is flush with the disc
`space.
`
`• Load appropriately sized blades onto
`the Retractor. The Retractor is then
`introduced into the space over the
`Second Dilator using a clockwise to
`counterclockwise motion until the
`Retractor is flush with the disc space.
`
`fJ
`ATEC LLIF000167282
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`Lateral lnterbody Fusion - Surgical Technique Guide
`D DISC SPACE ACCESS
`
`• Secure the Articulating Arm bed-rail
`attachment to the surgical table.
`Attach the Articulating Arm post to
`the Bed-rail Clamp and adjust to the
`preferred height. The opposite end of
`the Arm will then be attached to the
`Retractor.
`
`• The Articulating Arm can be attached
`to the Retractor in two positions.
`
`• Position 1 holds the posterior blade
`stationary while the cranial and caudal
`blades are free to traverse when the
`A/P Dial is rotated.
`
`• Position 2 holds the cranial and caudal
`blades stationary while the posterior
`blade is free to traverse when the A/P
`Dial is rotated.
`
`• Attach the Articulating Arm to the
`Retractor in the desired position.
`
`• Blades may be expanded
`independently cranially and caudally
`by squeezing the levers attached to
`the handles of the Retractor body.
`Blade toe may be increased by using
`the Blade Toe Driver. Care should
`be taken to avoid compromising the
`neural elements behind the center
`blade.
`
`a
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`ATEC LLIF000167283
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`Lateral lnterbody Fusion - Surgical Technique Guide
`D DISC SPACE ACCESS
`
`• Blades may also be raised or lowered
`using the wrench to accommodate
`patient anatomy. If a different length
`of blade is desired, blades may be
`changed by depressing the gold tab
`and removing the blade.
`
`• The Light Cable and the Light Source
`Connector are then placed halfway
`down the cranial and/or caudal blades
`and are bent away from the surgical
`path. Doing so helps visibility into the
`disc space.
`
`• Verify appropriate position of the
`Retractor with A/P fluoroscopy.
`
`• Confirm that no tissue or neural
`structures are compromised by the
`Retractor Blades during retraction .
`Use a Penfield to move any residual
`tissue behind the Retractor Blades.
`
`a
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`ATEC LLIF000167284
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`Lateral lnterbody Fusion - Surgical Technique Guide
`D DISC SPACE ACCESS
`
`• Place the lntradiscal Shim into the
`disc space through the center blade to
`stabilize the Retractor.
`
`• Expand the cranial and/or caudal
`blade to expose the disc space and
`gain desired access as needed for the
`procedure.
`
`• Retract the posterior blade to
`visualize the disc space, as needed.
`
`• Limit expansion of the Retractor to
`the disc space as over-expanding the
`retraction may cause unnecessary
`trauma to the psoas muscle.
`
`ATEC LLIF000167285
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`Lateral lnterbody Fusion - Surgical Technique Guide
`II DISC PREPARATION
`
`• Perform an annulotomy to
`accommodate the selected implant
`width (anterior to posterior) using the
`Annulotomy Knife.
`
`• A Cobb Elevator is then passed along
`the superior and inferior end plates to
`release the contralateral annulus.
`
`• Utilize additional disc preparation
`instrumentation such as Pituitary
`Rongeurs, End plate Scrapers, Kerrison
`Rongeurs, Chisels and Broaches to
`thoroughly prepare the disc space and
`endplates.
`
`IJ HYPERLORDOTIC APPLICATIONS
`
`• Retract the soft tissue directly
`anterior to the anterior longitudinal
`ligament (ALL) by gently inserting the
`4th Blade of the Squadron® Retractor
`anterior to the ALL but posterior to
`the great vessels. Secure the 4th
`Blade with the desired 4th Blade
`Attachment. After the 4th Blade is
`positioned and secured, incise the ALL
`with the desired cutting instrument
`under direct visualization.
`
`• Lateral spacers with >20° lordosis
`must be used with LIF AMP integrated
`fixation in addition to supplemental
`fixation. See LIF AMP Surgical
`Technique Guide, LIT-84883.
`
`& CAUTION! Resection of the anterio1
`longitudinal ligament (ALL] may
`facilitate insertion of the ldentiTH/F
`implant for greater sagittal correction,
`when used with AMP Anti-Migration
`Plate and supplemental fixation per
`the indications, and aid in preventinq
`potential endplote damaqe. To minimize
`1 isk to surrounding anatomy when
`1esecting the ALL, do not extend t he
`resection past the medial wall of the
`controloterol pedicle as identified on
`true AP f/uaroscopy
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`ATEC LLIF000167286
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`Lateral lnterbody Fusion - Surgical Technique Guide
`IJ 1tv1PLANT SIZING
`
`•
`
`Introduce a Primary Distractor to
`distract the disc space and estimate
`the appropriate implant height.
`
`• Attach the Handle to the Distractor by
`pulling back on the silver collar of the
`Handle and inserting the Distractor
`until the indentation is fully seated
`within the collar. Release the collar to
`lock the Distractor. Confirm locking by
`pulling on the Distractor.
`
`• The Distractor Handle may be
`removed once in place to facilitate
`fluoroscopy. Increase the Distractor
`size until the appropriate implant
`height is reached.
`
`• Using A/P fluoroscopy, impact the
`Trial into the disc space. Confirm
`correct size and width for the patient
`anatomy. The LIF Inserter Handle may
`be removed to facilitate fluoroscopic
`imaging.
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`ATEC LLIF000167287
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`m IMPLANT INSERTION
`
`• Choose the appropriate implant by
`width, length, lordosis, and height as
`determined by trialing.
`
`• Attach the implant to the Implant
`Inserter by lining up the implant's
`lateral notches with the tangs of the
`LIF Inserter. Depress the gold button,
`rotate the Inserter 180 degrees to
`lock the implant onto the Inserter.
`
`• Fill the implant graft windows with
`appropriate bone graft.
`
`• Confirm appropriate implant
`placement by using A/P fluoroscopy.
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`ATEC LLIF000167288
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`m SUPPLEMENTAL FIXATION
`
`• The Lateral lnterbody System is
`indicated for use with supplemental
`fixation including the lllico® MIS System,
`Arsenal® Spinal Fixation System, lllico®
`FS System, BridgePoint® Spinous
`Process Plate, Kodiak™ Spinal Fixation
`System, or lnvictus™ Spinal Fixation
`System. See INS-100 for instructions
`for use. See LIT-84883 for LIF AMP
`Surgical Technique.
`
`m CLOSURE
`
`• Close the wound using standard
`surgical techniques.
`
`m IMPLANT REMOVAL
`
`•
`
`If implant removal is necessary,
`access to the implantation site can
`be achieved in a similar fashion to
`the original access. Once the implant
`device is exposed, reattach the LIF
`Inserter and gently remove.
`
`•
`
`If the device is difficult to remove, the
`Implant Removal tool can be used.
`
`• Align the midline hole in the implant
`with the Removal tool and rotate
`the removal tool clockwise until the
`implant is firmly attached.
`
`• Remove the implant from the disc
`level. A Slap Hammer may be attached
`to the proximal portion of the removal
`tool to aid removal.
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`ATEC LLIF000167289
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`Lateral lnterbody Fusion - Surgical Technique Guide
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`ldentiTir.i Porous Ti lnterbody System
`
`GENERAL INFORMATION:
`The ldentiTi Porous Ti lnterbody Syst em is an intervertebral body fusion device w ith implants
`of vario us lengths1 widths, heights, and degrees of lordosis to accommodate individual patient
`anatomy. The ldentiTi interbody sp acers are manufactured from commercially pure titanium
`Grade 2 per ASTM F67. UF AMP integrated fixation is manufactured from titanium alloy (Ti-6Al-
`4V EU) per ASTM F1 36. The l dentiTi Porous Ti ceNical platform includes sub-system ldentiTi
`Cervical (ldentiTi-C). The ldentiTi Porous Tl thoracolumbar platform includes the following sub(cid:173)
`systems: ldentiTI-PS, ldentiTi-PC, ldenbTi-PO, ldentiTi ALlfc and ldentiTi-LIF.
`Use ldentiTi cervical interbody spacers w ith supplemental fix ation sy stems from Alphatec
`Spine such as: Trestle Luxe® Cervical Plate System.
`Use ldentiTi thoracolumbar interbody spacers w ith s upplemental fixation systems from
`Alphatec Spine such as: Zodiac® Polyaxial Spinal Fixat ion System, Arsenal® Spinal Fixation
`System, lllico® MIS Posterior Fixation System, BridgePoint® Spinous Proc ess Fi~ation
`System, or lnvictusTM Spinal Fixation System.
`
`INDICATIONS:
`ldentiTi Cervical Platform
`The ldentiTi Cervical Porous Ti lnterbody System is intended for spinal fusion procedures at one
`or two levels from C2 - T1 in skeletally mature patients w ith degenerative disc disease (DOD)
`of the cervical spine. ODD is defined as back pain of discogenic origin w ith degeneration of the
`disc confirmed by history and radiographic studies . The ld entiTi Cervical Porous Ti lnterbody
`System is intended for use with supplemental fixation systems and with autograft and/or
`allograft comprised of cancellous and/or corticocancellous bon e graft. Patients should have
`had six w eeks of non-operative treatment.
`ldentiTi Thoracolumbar Platform
`The ldentiTi Porous Ti lnterbody System is indicated f or spinal fusion procedures in skeletally
`mature patients at one or two contiguous levels in the thoracolumbar spine.
`Thoracic: T1-T2 to T1 1-T12, or at the thoracolumbar junction (T1 2-L1 ), following discectomy
`for the treatment of a sym ptomatic degenerative disc disease (DDD)1 including thoracic disc
`herniati on {myelopathy and/or radiculopathy w ith or w itho ut axial pain), The lateral approach is
`limited to levels T5-6 to T1 1-T1 2.
`Lumbar: L 1-l2 to L5-S1 , for the treatment of degenerative disc disease (ODD) with up to Grade I
`spoodylolisthesis or retrolisthesis at the involved leveKs). ODD is defined as back pain of discogenic
`ongin with degeneration otthe disc continned by history and radiographic studies.
`The ldentiTi Porous Ti lnterbody System is intended for use on patients who have had at least
`six months of non-operative treatment. It is intended for use w ith autograft and/or allograft
`comprised of cancellous and/or corticocancellous bone graft and supplemental fixation
`systems that are c leared by FDA for use in the thoracic and lumbar spine.
`UF Anti-Migration Plate (AMP) may be used with l dent iTi-LIF interbody spacers to provide
`int egrated fixation. ldentiTi-LIF spacers with >20° lordosis must be used with LIF AMP
`int egrated fbcation in addition to supplemental fixation. ldentiTi ALIF interbody spacers w ith
`>20° lordosis must be used w ith an anterior plate as the i orm of supplemental fixation
`
`CONTRAINDICATIONS:
`The ldentiTi Porous Ti lnterbody System is contraindicated for:
`1. Patients with b one resorption related disease (e.g.1 osteop enia)i bone and/or joint disease, or
`deficient soft tis sue at the wound site.
`2. Patients with infection, inflammation, fever, tumors, elevat ed white blood count, obesity,
`pregnancy1 mental illness1 and other medical conditions which would prohibit beneficial
`surgical outcome.
`3. Patients with allergy or intolerance to titanium.
`4. Patients resistant to following postoperative restrictions on movement especially in athletic
`and occupa1ional activities.
`5. Patients w ith prior fusion at th e level(s) to be treated,
`6. Spinal surgery cases that do not require bone grafting and/or spinal fusion.
`7. Reuse or multiple uses of th e implant.
`
`WARNINGS/CAUTIONS:
`1. The implants and single-use instruments are provided st etile.
`a. Do not re-sterilize implants.
`b. Do not use implants if pack age is o pened or damaged or if expiration date has passed.
`2. Components of this system should not be used with components from other systems or
`manufacturers .
`3. Do not comingle dissimi ar materials (e.g., titanium and stainless steel)wnhin the same construct.
`4. All instruments except the single-use instruments are provided non~sterile and must be
`cleaned and sterilized prior to surgery. See CLEANING and STERILIZATION sections in
`this IFU. Sterile single-use instruments are disposable devices, designed for single use and
`should not be reused or reprocessed. Reprocessing of single use instruments may lead to
`instrument damage and possible improp er function.
`5. Implants are single use devices. Do not reuse. While an implant may appear undamaged1
`it may have small defects or internal stress patterns that could lead to fatigue failure. In
`addition, the removed implant has not been designed or validated for the decontamination
`of microorganisms. Reuse of this product could lead to cross-infection and/or mat erial
`degradatioll as a result of the decontamination process.
`6. These implants are used only to provide internal fo:cation, in conjunctio n w ith graft and
`supplemental fixation, during the bone fusion process. A successful result may not be
`achieved in every instance.
`7. Potential risks identified with the use of these fusion devices, which may require additional
`surgery, include device component failure, loss of fixation, pseudarthrosis (i.e., non-union),
`fracture of the vertebra, neurological injury, and/or vascu lar or visceral injury
`8. Risk factors that may affect successful surgical outcomes include: alcohol abuse1 obesity1
`patients with poor b one, muscle and/or nerve quality, Patients w ho use tobacco or nicotine
`products should be advised of the consequences that an increased incidence of non-union
`has been reported w ith patients who use tobac co or n icotine products.
`9. It is critical that LIF AMP Center Screws are implanted using the appropriate instrument(s),
`
`e.g., Torque Handle. Failure t o tight en the Center Screws using the recommended
`instrument(s) could damage the Center Screw,
`
`PRECAUTIONS:
`1. Implantation should be performed only by experienced spinal surgeons with specific training
`in the use of this device because this is a technically demanding procedure p resenting a risk
`of serious injury to the patient.
`2. Installation and positional adjustment of implants must only be done with sp ecial 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
`3. Based on dynamic testing results, t he physician/surgeon should consider the levels of
`implantation, patient weight, patient activity level, other patient conditions, etc., which may
`affect the performance of this system.
`4. Patients with p,evious spinal surgery at the level(s) to be treated may have different clinical
`outcomes compared t o those without previous surgery.
`Resection of the anterior longitudinal ligament (ALL) may facilitate inserti on of the LIF implant
`for great er sagit tal correction, when used w ith UF AMP integrat ed fixation and supplemental
`fixation per the indications, and aid in preventing potential endplate damage. To minimize
`risk to surround ing anatomy when resecting the All, do not exte-nd the incision past the
`contralateral portio n of the retractor
`
`MAGNETIC RESONANCE (MR) SAFETY INFORMATION:
`The l dentiTi Porous Ti lnterbody System has not been evaluated for safety and compatibility in
`the magnetic resonance (M R) environment. It has not been tested for heating, migration, or image
`artifact in the MR environment. The safety of the ldentiTi Porous Ti lnterbody System in the MR
`environment is unknown. Scanning a patient who has this device may result in patient injury.
`
`POSSIBLE ADVERSE EFFECTS:
`Possibl e adverse effects include:
`1. Initial or delayed loosening, bending, dislocation, and/or breakage of device components.
`2. Physiological reaction to implant devices due to foreign body intolerance including
`inflammation, local tissue reaction, seroma, and possible tumor formation
`3. Loss of desired spinal curvature, spinal correction and/or a gain or loss in height.
`4. Infection and/or hemorrhaging .
`5. Non-union and/or pseudarthrosis ,
`6. Neurologic:al disorder, pain and/or abnormal sensations caused by improper placement of
`the device, and/or instruments.
`7. Subsidence of the device into the vertebral body.
`8. Revision surgery.
`9. Death
`
`PREOPERATIVE MANAGEMENT:
`1. Onfy patients meeting the criteria list ed in the indications for the use section should be selected.
`2. Surgeons should have a complete und erstanding of the surgical technique, system
`indications, contraindications, warnings and precautions, safety information, as well as
`functions and limitatio ns of the imp lants and instruments.
`3. Careful preoperative planning sho uld include imp lantation strategy and a verification of
`required inventory f or the case.
`4. The condition of all implant s and instrument s should be checked prior to use. Damaged and/
`or worn implants and instruments should not be used
`
`INTRAOPERATIVE MANAGEMENT:
`1. The surgical technique manual should be followed carefully.
`2. To prevent possible neNe damage and associated disorders, extreme caution should be
`taken to avoid the spinal cord and nerve roots at all times. Fluoroscopy should be employed
`where view o f device is obstructed.
`3. Bone graft must be placed in the area to be fused and graft material must extend from the
`upper to the lower vertebf'ae being fused.
`
`POSTOPERATIVE MANAGEMENT:
`Postoperative management by the surgeon is essential. T his includes instructing, warning , and
`monitoring the compliance of the patient.
`1. Patient should be informed regarding the purpose and limitations of the implanted devices.
`2. The surgeon should instruct the patient regarding the amount and time frame after surgery
`of any weight b earing activity. The increased risk of bending, dislocation, and/or breakage
`of the implanted devices, as well as an undesired surgical result are consequences of any
`type of early or excessive weight bearing, vibf'atory motion, falls, jolts or other movements
`preventing proper healing and/or fusion development
`3. Implanted devices should be revised or removed if bent, dislocated1 or broken.
`4. Immobilization should be considered in order to prevent bending, dislocation, or breakage
`of the implanted device in case of delayed 1 malunion, or nonunion of bone. Immobilization
`should continue until a complete bone fusion mass has developed and been confirmed .
`5. Postoperative patient s should be instructed not to use t obacco or nicotine products,
`consume alcohol, or use non-steroidal anti·inflammatory drugs and aspirin, as determined
`by the surgeon. Complete postoperative management to maintain the desired result should
`also follow implant surgery.
`
`&only Caution: Federal law (USA) restr icts these instruments t o sale
`
`by or on the order of a physician.
`
`Excerpt from INS-100
`
`ATEC LLIF0001 67290
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-12 Filed 01/18/20 PageID.22625 Page 17 of
` 19
`
`Lateral lnterbody Fusion - Surgical Technique Guide
`
`~~ te ("
`
`TranscendTM PEEK lnterbody System
`
`GENERAL INFORMATION:
`The Transcend PEEK lnterbody System is an intervertebral body fusion device with implants
`ot various lengths, w idths, heights1 and degrees of lordosis to accommodate individual patient
`anatomy. The Transcend interbody spacers are manufactured from PEEK {polyet heret herketone)
`Optima LT1 per ASTM F2026, tantalum per ASTM F560, and titanium alloy per ASTM F136. LIF
`AMP integrated fixation is manufactured from titanium alloy [Ti-6Al-4V ELI) per ASTM F136. The
`Transcend PEEK thoracolumbar platform includes t he following sub-system: Transcen.d-LJF.
`Use Transcend PEEK interbody spacers with supplemental fix ation systems from Alpha tee
`Spine such as: Zodiac® Polyaxial Spinal Fixation System1 Arsenal® Spinal Fixation System,
`lllico® MIS Posterior Fixation Syst em, BridgePoint® Spinous Process Fixation Syst em, or
`lnvictusTM Spinal F1Xation System
`
`INDICATIONS:
`The Transcend PEEK lnterbody System is indicated for spinal fusion procedures in skeletally
`mature patients at one or two contiguous levels in the thoracolumbar spine.
`Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction [T12-L1), lollowing discectomy
`for the treatment of a symptomatic degenerative disc d isease {ODD), including thoracic disc
`herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is
`limited to levels T5-6 to T11-T12.
`Lumbar: L 1-L2 to L5-S1, for the treatment of degenerative disc disease (DOD) with up to Grade
`I spondylolisthesis or retrolisthesis at the involved level(s). ODD is defined as back pain of
`discogenic origin with degeneration of the disc confirmed by history and radiographic studies
`The Transcend PEEK lnterbody System is intended for use on p atients who have had at least
`six months of non-operative treatment. It is intended for use with autograft and/or allograft
`comprised of cancellous and/or corticocancellous bone graft end supplemental fixation
`systems that are cleared by FDA for use in the thoracic and lumbar spine,
`LIF Anti-Migration Plate (AMP) may be used with Transcend-LIF interbody spacers to provide
`integrated fixation. Transcend-LIF spacers with >20° lordosis must be used with LIF AMP
`integrated fixation in addition to supplemental fixation.
`
`CONTRAINDICATIONS:
`The Transcen d PEEK lnterbody System is contraindicated for:
`1, Patients with bone resorption related disease (e.g., osteopenia)i bone and/or joint disease, or
`deficient soft tissue at the wound site.
`2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity,
`pregnancy, mental illness1 and other medical conditions which would prohibit beneficial
`surgical outcome.
`3, Patients with allergy or intolerance to titanium.
`4. Patients resistant to following postoperative restrictions on movement especially in athletic
`and occupational activities.
`5 . Patients with prior fusion at the level(s) to be treated.
`6 . Spinal surge,y cases that do not require bone grafting and/or spinal fusion.
`7. Reuse or multiple uses of the implant.
`
`WARNINGS/ CAUTIONS:
`1. The implants and single-use instruments are provided sterile
`a. Do not re-sterilize implants
`b. Do not use implants if p ackage is opened or damaged or if expiration date has passed
`2. Components of this system should not be used with components from other systems or
`manufacturers.
`3, Do not comingle dissimilar materials (e.g., titanium and stainless steel) within the same
`construct
`4. All instrument s except the single-use instrument s are provided non-sterile and must be
`c leaned and st erilized p,ior to surge,y. See CLEANING and STERILIZATI ON sections in
`this IFU. Sterile single-use instruments are disposable devices, designed for single use and
`should not be reused or reprocessed . Reprocessing of single use instruments may lead to
`instrument damage and possible improper function,
`5. Implants are single use devices. Do not reuse. While an implant may appear undamaged,
`it may have small defects or internal stress patterns that could lead to fatigue failure. In
`addition1 the removed implant has not been designed or validated for the decontamination
`of microorganisms. 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 internal fixation , in conjunction with graft and
`supplement al fixation, during the bone fusion process. A successful result may not be
`achieved in every instance.
`7. Potential risks identified with the use of these fusion devices, which may require additional
`surgery, include device component failure, loss of fixation, pseudarthrosis {i.e., non-union),
`fracture of the vertebra, neurological injury, and/or vascular or visceral injury,
`8, Risk factors that may affect successful surgical outcomes include: alcohol abuse, obesity1
`patients with poor bone 1 muscle and/or nerve quality. Patients who use tobacco or nicotine
`products should be advised of the consequences that an increased incidence of non-union
`has been reported with patients who use tobacco or nicotine products.
`9 . It is critical that LIF AMP Center Screws are implanted using the appropriat e instrument(s),
`e.g., Torque Handle. Failure to tighten the Center Screws using the recommended
`instrument{s) could damage the Center Screw,
`
`PRECAUTIONS:
`1. Implantation should be performed only by experienced spinal surgeons with specific training
`in the use of this devic e because this is a technically demanding procedure presenting a risk
`of serious injury to the patient.
`2, Installation and positional adjustment of implants must only be done with special equipment
`and instruments specific to these devices. They must n ot be used with other instrumentation
`unless specifically recommended by Alphatec Spine Inc., because the combination with
`other instrumentation may be incompatible .
`
`3. Based on dynamic testing results, the physician/surgeon should consider the levels of
`implantation1 patient weight, patient activity level1 other patient conditions, etc., which may
`affect the performance of this system.
`4. Patients with previo us spinal surge,y at the lev el(s) to be treat ed may have different clinical
`outcomes compared to those without previous surgery.
`Resection of the anterior longitudinal ligament (ALL) may facilitate insertion of the UF implant
`for greater sagittal correction, when u sed with LIF AMP integrated fixation and supplemental
`fixation per the indications1 and aid in preventing potential endplate damage. To minimize risk to
`surrounding anatomy when resecting the ALL, do not extend the incision past the contralateral
`portion of the retractor.
`
`MAGNETIC RESONANCE (MR) SAFETY INFORMATION:
`The Transcend PEEK lnterbody System has not been evaluat ed for safety and compatibility
`in the magnetic resonance (MR) environment. It has not been tested for heating 1 migration1 or
`image artifact in the MR environment. The safety