Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10198 Page 1 of 65
`
`EXHIBIT Y
`
`TO THE REPLY DECLARATION OF JIM A. YOUSSEF, M.D.
`
`IN SUPPORT OF NUVASIVE’S MOTION FOR
`PRELIMINARY INUNCTION
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10199 Page 2 of 65
`
`Surgical Technique
`
`
`
`
`
`LLIF Procedure
`
` Lateral Lumbar Interbody Fusion
`
`
`
`with MARS™3V & TransContinental®
`
`Exhibit Y
`Page 221
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10200 Page 3 of 65
`
`At Globus, we move with a sense of urgency to
`deliver innovations that improve the quality of life
`for patients with spinal disorders. We are inspired
`by the needs of these patients and also the needs
`of the surgeons and health care providers who
`treat them.
`
`the techniques and outcomes of spine surgery
`so patients can resume their lives as quickly as
`possible. We extend our reach beyond our world
`class implants, instrumentation, and service by
`partnering with researchers and educators to
`advance the science and knowledge of spine care.
`
`This passion combined with Globus’ world class
`engineering transforms clinical
`insights
`into
`tangible spine care solutions. We are driven to
`provide the highest quality products to improve
`
`The energy and enthusiasm each of us bring
`everyday to Globus is palpable. We are constantly
`in the pursuit of better patient care and understand
`that speed is critical because life cannot wait.
`
`2 |
`
`www.globusmedical.com
`
`Exhibit Y
`Page 222
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10201 Page 4 of 65
`
` Lateral Lumbar Interbody Fusion
`
`LLIF
`
`The use of a lateral approach to access the thoracolumbar
`spine has been well documented in literature. in the late
`19th century (1894), Menard developed a procedure
`that allowed greater exposure to the lateral aspect of the
`spine. capener, in 1954, built on Menard’s advances for
`the treatment of Pott disease (tuberculosis of the spine).1, 2
`however, their procedures had limitations.
`
`During the past 35 years, surgeons have continued to
`develop the lateral technique. in 1976 Fraser et al. described
`a muscle splitting approach to the lumbosacral spine. The
`exposure gained with this retroperitoneal technique offered
`successful access to the mid-lumbar and lumbosacral spine.3
`O’Brien analyzed his many patients that underwent a left-
`sided, retroperitoneal approach. The benefit of this was
`avoidance of canal trauma and elimination of motion by
`using a large graft.4 Mcafee et al. presented the first clinical
`series investigating the use of the lateral retroperitoneal
`approach for fusion from l1-l5, reporting an overall lower
`morbidity comparable to traditional approaches.5 Building
`on this, Bertagnoli developed the anterolateral transpsoatic
`approach for accessing the lumbar disc while avoiding
`disruption to the posterior elements.6 Today, globus
`has refined the lateral approach with the introduction of
`MarS™3V and Transcontinental®.
`
`1 Ménard V: Causes de la paraplégie dans le mal de Pott. rev Orthop: 47–64, 1894.
`2 capener n: The evolution of lateral rhacotomy. J Bone Joint Surg Br 36: 173-179, 1954.
`3 Fraser rD, gogan WJ. A Modified Muscle-Splitting Approach to the Lumbosacral Spine. Spine
`17(8): 943-8, 1992.
`4 Kozak J, O’Brien J. Simultaneous Combined Anterior and Posterior Fusion. an independent
`analysis of a Treatment for the Disabled low-Back Pain Patient Spine 15(4): 322-328, 1990.
`5 Mcafee P et al. Minimally Invasive Anterior Retroperitoneal Approach to the Lumbar Spine:
`Emphasis on the Lateral BAK. Spine 23(13): 1476-1484, 1998.
`6 Bertagnoli r, Vazquez rJ. The Anterolateral TransPsoactic Approach(ALPA): a new technique for
`implanting prosthetic disc-nucleus devices. J Spinal Disord Tech 16(4): 398-404, 2003.
`
`LLIF Procedure | 1
` LLIF Procedure | 1
`
`Exhibit Y
`Page 223
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10202 Page 5 of 65
`
`LLIF
`LateraL Lumbar Interbody FusIon
`
`The MiS lateral approach has been refined with the combination of the MarS™3V retractor and the
`Transcontinental® spacer system.
`MarS™3V is a versatile and variable vision system that gives unprecedented control of tissue retraction
`during the entire procedure.
`Transcontinental® is a comprehensive spacer system with extensive instrumentation.
`
`mars™3V
`The MarS™3V retractor provides the versatility, stability, and precision
`required to access hard-to-reach disc spaces.
` • Independent blade retraction
` • Individual blade angulation up to 20°
` • Lightweight, aluminum components for radiolucency
` • Illumination system fits within blade walls for less bulk
`
`transContinental®
`The Transcontinental® System is ideal for a minimally invasive
`approach to help preserve patient anatomy.
` • Self-distracting leading edge for ease of insertion
` • Radiographic positioning markers for implant placement and
`orientation
` • Comprehensive disc preparation instrumentation
` • Trial length indicators provide accurate length assessment on
`fluoroscopy
`
`large surface area with
`pyramidal teeth for
`maximum engagement
`
`large single graft window
`for solid fusion mass
`
`leading edge self-distracts
`on insertion
`
`2 |
`
`Exhibit Y
`Page 224
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10203 Page 6 of 65
`
`Contents
`
`Distinguishing characteristics
`
`MarS™3V retractor Overview
`
`implant Overview
`
`instrument Overview
`
`Surgical Technique
`
`
`
`
`
`
`
`
`
`
`
`
`
`1. Patient Preparation
`
`2. initial Dilator insertion
`
`3. retractor insertion
`
`4. Disc Preparation
`
`5. interbody insertion
`
` Using the Implant Insertion Tool
`
`Final Position
`
`Transcontinental® implant Set
`
`MarS™3V retractor Set
`
`MarS™ instrument ii Set
`
`anterior Disc Prep i instrument Set
`
`anterior Disc Prep ii instrument Set
`
`lateral Disc Prep instrument Set
`
`Transcontinental® insertion instruments Set
`
`lateral angled Disc Prep instrument Set
`
`Transcontinental® angled Trials Set
`
`Transcontinental® 16mm Wide implant Set
`
`Bayonetted Disc Prep instrument Set
`
`Transcontinental® 22mm implant Set
`
`Transcontinental® 10° Lordotic Implant Set
`
`Transcontinental® coronal Tapered implant Set
`
`important information
`
`2
`
`4
`
`5
`
`6
`
`16
`
`18
`
`19
`
`25
`
`26
`
`27
`
`28
`
`30
`
`32
`
`34
`
`36
`
`38
`
`40
`
`42
`
`44
`
`46
`
`48
`
`49
`
`50
`
`52
`
`54
`
`56
`
`The Surgical Technique shown is for illustrative purposes only. The technique(s) actually employed in each case always depends on the medical
`judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient. Additionally, as instruments may
`occasionally be updated, the instruments depicted in this Surgical Technique may not be exactly the same as the instruments currently available.
`Please consult with your sales representative or contact Globus directly for more information.
`LLIF Procedure | 3
`
`Exhibit Y
`Page 225
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10204 Page 7 of 65
`
`mars™3V retraCtor oVerVIew
`
`guided light Source
`
`extra Wide cephalad-caudad Blades
`
`radiolucent arm
`
`retractor center Fixation Mount
`
`Posterior Blade Fixation Mount
`
`low-Profile 18mm inner Diameter
`
`Blade lock
`
`individual Blade
`angulation Knob
`
`independent Blade
`retraction Knob
`
`4 |
`
`Exhibit Y
`Page 226
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10205 Page 8 of 65
`
`ImPLant oVerVIew
`
`transContinental® spacer
`
`transContinental® Instrumentation
`
`• Self-distracting leading edge
`
`• MIS compatible system
`
`• Large single chamber for bone graft material
`
`• Each trial provides precise length measurements
`
`• Five axial footprints
`
`• Three sagittal profiles (0°, 6° and 10° Lordotic)
`
`• Heights of 7–17 mm in 2mm increments
`
`• Pyramidal teeth resist migration
`
`• Holder with sleeve eliminates challenges with
`implant disengagement
`
`height
`
`lordosis
`
`LLIF Procedure | 5
`
`35mm
`
`30mm
`
`25mm
`
`20mm
`
`16mm
`
`16mm
`
`16mm
`
`16mm
`
`60mm
`
`55mm
`
`50mm
`
`45mm
`
`40mm
`
`18mm
`
`22mm or
`
`18mm
`
`22mm or
`
`18mm
`
`22mm or
`
`18mm
`
`22mm or
`
`16mm
`
` 18mm or
`
`22mm,
`
`Exhibit Y
`Page 227
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10206 Page 9 of 65
`
`Instrument oVerVIew
`
`access Instruments
`
`K-Wire gripper 623.003
`
`K-Wire, 350mm 675.399S
`
`Fluoro Modulator 675.403
`
`incision locator 675.404
`
`initial Dilator holder 675.800
`
`cannula a 698.205
`
`cannula B 698.210
`
`cannula c 698.215
`
`cannula D 698.220
`
`6 |
`
`Exhibit Y
`Page 228
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10207 Page 10 of
`65
`
`retractor assembly
`
`Retractor Blades
`Posterior Blade
`698.450
`698.452
`698.454
`698.456
`698.458
`698.460
`698.462
`698.464
`698.466
`698.468
`698.470
`698.472
`698.474
`698.476
`
`cc Blade
`698.510
`698.512
`698.514
`698.516
`698.518
`698.520
`698.522
`698.524
`698.526
`698.528
`698.530
`698.532
`698.534
`698.536
`
`length
`40mm
`50mm
`60mm
`70mm
`80mm
`90mm
`100mm
`110mm
`120mm
`130mm
`140mm
`150mm
`160mm
`170mm
`
`Posterior Blade
`
`cc Blade
`
`retractor 3 Blade Frame 698.100
`
`Table clamp 632.500
`
`articulating arm assembly 632.750
`
`LLIF Procedure | 7
`
`Exhibit Y
`Page 229
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10208 Page 11 of
`65
`
`retractor Instruments
`
`Suction 8” 675.513
`
`10mm Socket Driver 632.150
`
`Frame handle 698.230
`
`hook and latch Driver 698.250
`
`Shim Tool 698.230
`
`Docking Pin Tool 698.260
`
`Disc Shim Tool 698.330
`
`Docking Pin Sleeve 698.350
`
`8 |
`
`Exhibit Y
`Page 230
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10209 Page 12 of
`65
`
`Light Components
`
`MiS illumination System 675.725S
`
`Fiber Optic cord 632.300
`
`adapter, acMi 632.305
`
`adapter, Wolf 632.306
`
`adapter, Olympus 632.307
`
`adapter, Storz 632.308
`
`LLIF Procedure | 9
`
`Exhibit Y
`Page 231
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10210 Page 13 of
`65
`
`disc Prep Instruments
`
`Bayonetted annulotomy Knife 675.405S
`
`cobb elevator, Straight, 20mm 675.503
`
`cobb elevator, Straight, 10mm 675.504
`
`rasp 675.505
`
`Disc rotary cutter 675.506
`
`Disc Box cutter 675.507
`
`10 |
`
`Exhibit Y
`Page 232
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10211 Page 14 of
`65
`
`disc Prep Instruments (cont'd)
`
`Thin rasp, 12x20mm 675.510
`
`Cobb, 7° Up-Angled, 10mm 675.515
`
`Cobb, 7° Up-Angled, 10mm 675.516
`
`Kerrison, 4mm 625.202
`Kerrison, 6mm 625.203
`
`Disc rongeur, 4mm 625.305
`Disc rongeur, 4mm, up Biting 625.306
`Disc rongeur, 6mm 625.307
`
`LLIF Procedure | 11
`
`Exhibit Y
`Page 233
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10212 Page 15 of
`65
`
`height
`
`Part number
`
`7mm
`
`9mm
`
`11mm
`
`13mm
`
`15mm
`
`17mm
`
`675.607
`
`675.609
`
`675.611
`
`675.613
`
`675.615
`
`675.617
`
`scrapers
`
`Curettes
`
`cobb elevator, angled, 18mm 625.102
`
`ring curette, 10mm 625.401
`
`ring curette, 15mm 625.402
`
`12 |
`
`Exhibit Y
`Page 234
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10213 Page 16 of
`65
`
`Curettes (cont'd)
`
`Bone curette, 7.5 x 11.5mm, Straight 625.407
`
`Bone curette, 7.5 x 11.5mm, up-angled 625.408
`
`ring curette, 10mm, Straight 675.518
`
`Ring Curette, 10mm, 7° Up-Angled 675.519
`
`cup curette, 6.5 x 9.5mm, Straight 675.525
`
`Cup Curette, 6.5 x 9.5mm, 15° Up-Angled 675.526
`
`Cup Curette, 6.5 x 9.5mm, 90° Down-Angled 675.527
`
`LLIF Procedure | 13
`
`Exhibit Y
`Page 235
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10214 Page 17 of
`65
`
`Handles
`
`T-handle 675.005
`
`l-handle 679.010
`
`Insertion Instruments
`
`Trial, Parallel
`
`Trial, lordotic
`
`height
`5mm
`7mm
`9mm
`11mm
`13mm
`15mm
`17mm
`
`Trials
`Parallel
`675.006
`675.007
`675.009
`675.011
`675.013
`675.015
`675.017
`
`Lordotic 6°
`675.106
`675.107
`675.109
`675.111
`675.113
`675.115
`675.117
`
`14 |
`
`Exhibit Y
`Page 236
`
`

`

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`65
`
`Insertion Instruments (cont'd)
`
`Slide hammer, long 675.004
`
`implant insertion Tool 664.500
`
`insertion Sleeve 675.501
`
`Implant Insertion Tool 664.500,
`Insertion Sleeve 675.501 (Assembled)
`
`implant Positioner 675.502
`
`LLIF Procedure | 15
`
`Exhibit Y
`Page 237
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10216 Page 19 of
`65
`
`LLIF
`surgICaL teCHnIque
`
`
`Step
`
`1
`
`
`Patient Preparation
`
`Patient Positioning
`
`The patient is placed on a flexible surgical table in a true
`90° right lateral decubitus position so that the iliac crest
`is just over the table break, as shown below.
`
`The patient is then secured to the table at the following
`locations: (1) Just beneath the iliac crest; (2) Over the
`thoracic region, just under the shoulder; (3) From the
`back of the table, over the ankle, and (4) past the knee
`to the front of the table.
`
`The table should be flexed to open the interval
`between the 12th rib and iliac crest, and provide direct
`access to the disc space as shown below.
`
`2
`
`1
`
`4
`
`3
`
`Patient secured to table
`
`Patient positioning
`
`16 |
`
`Table flexed
`
`Exhibit Y
`Page 238
`
`

`

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`65
`
`X-Ray Confirmation
`
`Fluoroscopy is used to ensure that the spine is oriented in a true lateral position. The table should be adjusted so
`that the C-arm provides true AP images when at 0° and true lateral images at 90°.
`
`lateral image
`
`aP image
`
`Incision Location
`
`The operative area is carefully cleaned and the Incision Locator is used under fluoroscopy to identify the middle
`of the disc space to be fused. An access incision mark is then traced on the patient’s skin to indicate the position
`and insertion site for the retractor.
`
`anTeriOr
`
`POSTeriOr
`
`access
`incision
`
`using incision locator
`
`Marking the incision locations
`
`LLIF Procedure | 17
`
`Exhibit Y
`Page 239
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10218 Page 21 of
`65
`
`
`Step
`
`2
`
`
`initial Dilator insertion
`
`The initial dilator is inserted and AP fluoroscopy is used to confirm proper initial dilator alignment. A K-wire is
`inserted through the initial dilator into the disc space, in preparation for sequential dilation.
`
`The Initial Dilator Holder may be used to steady the dilator and maintain distance from x-ray field while imaging.
`
`initial dialor position
`
`K-wire inserted
`
`Sequential Dilation
`
`With the K-wire in place, a series of cannulas
`are passed over the initial dilator, spreading
`the tissue to prepare for retractor insertion.
`
`Cannula D should only be used if additional
`dilation is necessary following Cannula B,
`C. However, if Cannula D is used, it must be
`removed prior to insertion of the retractor.
`
`Blade Length
`
`Depth markings on each cannula are used
`to estimate retractor blade length. The
`targeted depth indicator will be the first
`visible marking above the incision site. To
`ensure sufficient length, 10mm should be
`added to the blade length reading.
`
`18 |
`
`Exhibit Y
`Page 240
`
`

`

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`65
`
`
`Step
`
`3
`
`
`retractor insertion
`
`Retractor Assembly
`
`cc Blade
`
`Select the appropriate blades and insert into each of the three
`blade mounts of the Retractor 3 Blade Frame.
`
`The Posterior Blade is inserted into the posterior blade mount.
`
`The CC Blades (cephalad-caudal) are inserted into the cephalad
`and caudal blade mounts.
`
`cc Blade
`
`Posterior Blade
`
`Posterior Blade
`
`cc Blade
`
`Ensure that the blades are properly seated into the retractor at each of the three
`positions. Secure the blades using the Hook and Latch Driver. Position the
`driver on the latch and rotate 90° clockwise to lock the blade in place.
`
`The blades can be changed intraoperatively when a different blade length is
`required. The blades have angled holes that accept the driver. Insert the hook
`and tighten down the white sleeve to hold the blade securely. This provides a
`secure connection to remove the blade.
`
`using the hook and latch Driver
`to secure blades
`
`using the hook and latch Driver to
`change blades
`
`LLIF Procedure | 19
`
`Exhibit Y
`Page 241
`
`

`

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`65
`
`retractor insertion (cont'd)
`
`Retractor Positioning
`
`Ensure that the retractor is in the fully closed position and
`the blades are securely attached to the frame. The access
`incision should allow the blades to retract and angulate.
`
`Slide the retractor over Cannula C and apply gentle
`downward pressure on the frame.
`
`Before removing the cannulas, angulate all three blades to
`one full turn of the silver knobs. Retract all three blades
`to two clicks using the gold knobs, starting with the blade
`closest to the iliac crest. Angulating and retracting the
`blades in this manner will help prevent tissue creep as the
`cannulas are removed.
`
`Once the retractor has been securely positioned and
`the Articulating Arm Assembly tightened, remove
`the cannulas and verify position of the retractor before
`removing the k-wire.
`
`Use AP fluoroscopy to verify the correct positioning on
`the spine and to confirm that retractor blades are parallel
`with the disc space.
`
`Table Arm Attachment
`
`Attach the Table Clamp over the drape and onto the bed
`rail attachment. Insert the Articulating Arm Assembly into
`the clamp and secure.
`
`The opposite end of the assembly arm is then attached
`to the retractor. There are two options for attachment
`positions on the retractor, as shown at right.
`
`Attaching the arm assembly to point A maintains retractor
`position relative to the posterior blade position and
`translates the cephalad and caudad blades anteriorly when
`the retractor is opened.
`
`Attaching the arm assembly to point B maintains the
`retractor position relative to the center of the frame and
`retracts all three blades when the retractor is opened.
`
`Positioning retractor
`
`B
`
`a
`
`20 |
`
`articulating arm attachment locations
`
`Exhibit Y
`Page 242
`
`

`

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`65
`
`Table Arm Attachment (cont’d)
`
`Insert the Articulating Arm Assembly
`into the desired attachment position and
`tighten the thumb screw using the 10mm
`Socket Driver. Position the arm and lock
`in place by tightening the black star handle
`on the arm assembly.
`
`Minimal torque is required to tighten the
`thumb screw with the driver.
`
`Manipulation of the retractor can be
`achieved with the Frame Handle that fits
`over arm attachment point B.
`
`Light Cable Insertion
`
`The MIS Illumination System has two
`light cables which can be inserted into the
`CC Blades.
`
`The light cables should be inserted through
`the blade to a depth providing optimal
`visibility.
`
`The Fiber Optic Cord attaches to the light
`source used for head lamps or endoscopes.
`The adapters accommodate an ACMI,
`Olympus, Storz, or Wolf light source.
`
`Note: The Fiber Optic Cord is reusable and must
`not be discarded.
`
`using a Frame handle
`
`LLIF Procedure | 21
`
`Exhibit Y
`Page 243
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10222 Page 25 of
`65
`
`retractor insertion (cont'd)
`
`Cephalad-Caudad Blade Anchoring
`
`For additional retractor stability, Docking Pins can be
`inserted into the vertebral body through the CC Blades
`to increase retractor stability when expanding blades for
`greater exposure as shown below.
`
`Select the appropriate size pin and insert into the
`Docking Pin Sleeve. The pin assembly can slide down
`the T-slot on either side of the blade. The Docking Pin
`Tool has a hex feature that mates with the head of the
`pin. Rotate the tool clockwise to engage pin threads into
`the bone.
`
`To remove the pins, re-engage the hex of the tool into
`the pin head and rotate counterclockwise to disengage
`from the bone.
`
`Docking pin
`assembly
`
`Docking pin
`assembly loaded
`
`22 |
`
`Exhibit Y
`Page 244
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10223 Page 26 of
`65
`
`Blade Expansion
`
`Each blade may be independently expanded using the 10mm Socket Driver to rotate the respective gold hex nut
`in the direction indicated by the arrow.
`
`Each blade may be angled up to 20° using the driver. Place the driver onto the silver hex nut and rotate the
`instrument clockwise, allowing the blade to tilt to the desired position.
`
`Blade expansion
`
`Blade angulation
`
`LLIF Procedure | 23
`
`Exhibit Y
`Page 245
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10224 Page 27 of
`65
`
`retractor insertion (cont'd)
`
`Blade Expansion (cont'd)
`
`Widening Shim
`While expanding the CC Blades, Widening Shims can be
`used to help prevent soft tissue creep between blades.
`
`The Shim Tool, CC, is used to slide the Widening Shim
`down the T-slot on either side of the blades, for an
`additional 22mm of blade width.
`
`Lengthening Shim
`While angulating the CC Blades, Lengthening Shims can
`be used to help prevent soft tissue creep between blades by
`increasing the length of the blade to maintain bone contact.
`
`The Shim Tool, CC, is used to push the Lengthening Shim
`down the right T-slot of the blades.
`
`Shim Removal
`Both Widening and Lengthening Shims have angled holes to
`accept the hook on the Shim Tool, CC. Insert the hook and
`pull upward to remove the shim.
`
`24 |
`
`Exhibit Y
`Page 246
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10225 Page 28 of
`65
`
`
`Step
`
`4
`
`
`Disc Preparation
`
`Annulotomy
`
`The Bayonneted Annulotomy Knife is used to
`create a window centered in the anterior half of the
`annulus large enough for graft insertion.
`
`Contralateral Annulus Release
`
`A Cobb Elevator is passed along both endplates
`through the disc space, far enough to provide
`release of the contralateral annulus. This allows for
`height restoration upon insertion of the implant.
`
`Disc Space Preparation
`
`Leaving the posterior annulus intact, remove the
`intervertebral disc and osteophytes as needed. The
`Disc Box Cutter, Rotary Cutter, Disc Rongeurs,
`Kerrisons, Curettes, Scrapers and Rasps are
`provided for disc removal and endplate preparation,
`as shown at right.
`
`using the cobb elevator
`
`using the Disc rongeur
`
`LLIF Procedure | 25
`
`Exhibit Y
`Page 247
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10226 Page 29 of
`65
`
`
`Step
`
`5
`
`
`interbody insertion
`
`Implant Sizing
`
`To determine the appropriate spacer size for the desired segment,
`first insert the smallest Trial into the disc space, moving to larger
`trials as needed. Determine which trial best fits the prepared disc
`space. A secure fit is desirable in order to maintain disc height
`and stabilize the segment. Use AP fluoroscopy to confirm that
`the implant is centered and lateral fluoroscopy to ensure that the
`implant is in the appropriate AP position.
`
`The trial’s anterior side is labeled “Anterior” and matches the
`profile of the TransContinental® Spacer.
`
`implant Sizing
`(55mm disc space is shown)
`
`55mm
`
`45mm
`
`60mm
`
`50mm
`
`40mm
`
`Implant Insertion
`
`Select the appropriately sized TransContinental® Spacer
`and gently insert into the intervertebral space using the
`Implant Holder and Tamp. AP fluoroscopy should be
`used to facilitate implant placement.
`
`Once the position is confirmed, the implant is released
`from the holder.
`
`The TransContinental® Spacer is intended to be used
`with supplemental fixation.
`
`26 |
`
`implant insertion
`
`Exhibit Y
`Page 248
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10227 Page 30 of
`65
`
`Using the Implant Insertion Tool
`
`Ensure the Implant Insertion Tool is in the unlocked position. Thread the implant to the tool by
`rotating the handle clockwise. Lock the tool by sliding the locking nut forward. Insert the implant. To
`disengage, unlock and rotate the handle counterclockwise.
`
`impaction cap
`
`unlocked
`
`locked
`
`Closure
`
`Once the procedure is completed, use the 10mm Socket Driver to angle all blades to the 0° starting position. Return
`all blades to the closed position by compressing the three release tabs on the back and sides of the retractor.
`
`close angle
`
`release Tab
`
`release Tab
`
`release Tab
`
`LLIF Procedure | 27
`
`Exhibit Y
`Page 249
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10228 Page 31 of
`65
`
`Final Position
`
`aP view
`(radiographic markers shown)
`
`Sagittal view
`(radiographic markers shown)
`
`28 |
`
`Exhibit Y
`Page 250
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10229 Page 32 of
`65
`
`axial view
`
`5mm
`
`2.25mm
`
`2.25mm
`
`3mm
`
`radiographic markers positions
`
`LLIF Procedure | 29
`
`Exhibit Y
`Page 251
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10230 Page 33 of
`65
`
`transContinental® ImPLant set
`
`
`
`
`
`30 | 30 | 30 |
`
`Exhibit Y
`Page 252
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10231 Page 34 of
`65
`
`transContinental® Implant set 975.916
`
`Part No. Description
`
`Qty
`
`Part No. Description
`
`Qty
`
`375.007 Transcontinental® Spacer, Small, 0°, 7mm
`
`375.009 Transcontinental® Spacer, Small, 0°, 9mm
`
`375.011 Transcontinental® Spacer, Small, 0°, 11mm
`
`375.013 Transcontinental® Spacer, Small, 0°, 13mm
`
`375.015 Transcontinental® Spacer, Small, 0°, 15mm
`
`375.017 Transcontinental® Spacer, Small, 0°, 17mm
`
`375.107 Transcontinental® Spacer, Small, 6°, 7mm
`
`375.109 Transcontinental® Spacer, Small, 6°, 9mm
`
`375.111 Transcontinental® Spacer, Small, 6°, 11mm
`
`375.113 Transcontinental® Spacer, Small, 6°, 13mm
`
`375.115 Transcontinental® Spacer, Small, 6°, 15mm
`
`375.117 Transcontinental® Spacer, Small, 6°, 17mm
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 1
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 1
`
`375.513 Transcontinental® Spacer, Large, 6°, 13mm
`
` 2
`
`375.515 Transcontinental® Spacer, Large, 6°, 15mm
`
` 2
`
`375.517 Transcontinental® Spacer, Large, 6°, 17mm
`
` 1
`
`375.607 Transcontinental® Spacer, X-Large, 0°, 7mm
`
` 2
`
`375.609 Transcontinental® Spacer, X-Large, 0°, 9mm
`
` 2
`
`375.611 Transcontinental® Spacer, X-Large, 0°, 11mm 2
`
`375.613 Transcontinental® Spacer, X-Large, 0°, 13mm 2
`
`375.615 Transcontinental® Spacer, X-Large, 0°, 15mm 2
`
`375.617 Transcontinental® Spacer, X-Large, 0°, 17mm 1
`
`375.707 Transcontinental® Spacer, X-Large, 6°, 7mm
`
` 2
`
`375.709 Transcontinental® Spacer, X-Large, 6°, 9mm
`
` 2
`
`375.711 Transcontinental® Spacer, X-Large, 6°, 11mm 2
`
`375.207 Transcontinental® Spacer, Medium, 0°, 7mm 2
`
`375.713 Transcontinental® Spacer, X-Large, 6°, 13mm 2
`
`375.209 Transcontinental® Spacer, Medium, 0°, 9mm 2
`
`375.715 Transcontinental® Spacer, X-Large, 6°, 15mm 2
`
`375.211 Transcontinental® Spacer, Medium, 0°, 11mm 2
`
`375.717 Transcontinental® Spacer, X-Large, 6°, 17mm 1
`
`375.213 Transcontinental® Spacer, Medium, 0°, 13mm 2
`
`375.807 Transcontinental® Spacer, X-Small, 0°, 7mm
`
` 2
`
`375.215 Transcontinental® Spacer, Medium, 0°, 15mm 2
`
`375.809 Transcontinental® Spacer, X-Small, 0°, 9mm
`
` 2
`
`375.217 Transcontinental® Spacer, Medium, 0°, 17mm 1
`
`375.811 Transcontinental® Spacer, X-Small, 0°, 11mm 2
`
`375.307 Transcontinental® Spacer, Medium, 6°, 7mm 2
`
`375.813 Transcontinental® Spacer, X-Small, 0°, 13mm 2
`
`375.309 Transcontinental® Spacer, Medium, 6°, 9mm 2
`
`375.815 Transcontinental® Spacer, X-Small, 0°, 15mm 2
`
`375.311 Transcontinental® Spacer, Medium, 6°, 11mm 2
`
`375.817 Transcontinental® Spacer, X-Small, 0°, 17mm 1
`
`375.313 Transcontinental® Spacer, Medium, 6°, 13mm 2
`
`375.907 Transcontinental® Spacer, X-Small, 6°, 7mm
`
` 2
`
`375.315 Transcontinental® Spacer, Medium, 6°, 15mm 2
`
`375.909 Transcontinental® Spacer, X-Small, 6°, 9mm
`
` 2
`
`375.317 Transcontinental® Spacer, Medium, 6°, 17mm 1
`
`375.911 Transcontinental® Spacer, X-Small, 6°, 11mm 2
`
`375.407 Transcontinental® Spacer, Large, 0°, 7mm
`
`375.409 Transcontinental® Spacer, Large, 0°, 9mm
`
` 2
`
` 2
`
`375.913 Transcontinental® Spacer, X-Small, 6°, 13mm 2
`
`375.915 Transcontinental® Spacer, X-Small, 6°, 15mm 2
`
`375.411 Transcontinental® Spacer, Large, 0°, 11mm
`
` 2
`
`375.917 Transcontinental® Spacer, X-Small, 6°, 17mm 1
`
`375.413 Transcontinental® Spacer, Large, 0°, 13mm
`
` 2
`
`975.011 Transcontinental® graphic case – implants
`
`375.415 Transcontinental® Spacer, Large, 0°, 15mm
`
` 2
`
`375.417 Transcontinental® Spacer, Large, 0°, 17mm
`
` 1
`
`375.507 Transcontinental® Spacer, Large, 6°, 7mm
`
`375.509 Transcontinental® Spacer, Large, 6°, 9mm
`
` 2
`
` 2
`
`375.511 Transcontinental® Spacer, Large, 6°, 11mm
`
` 2
`
`LLIF Procedure | 31
`
`Exhibit Y
`Page 253
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10232 Page 35 of
`65
`
`mars™3V retraCtor set
`
`11
`
`13
`
`10
`
`12
`
`15
`
`6
`
`7
`
`16
`
`19
`
`9
`
`4 1
`
`8
`
`2
`
`5
`
`3
`
`18
`
`14
`
`17
`
`
`
`32 | 32 |
`
`Exhibit Y
`Page 254
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10233 Page 36 of
`65
`
`mars™3V retractor set 998.901
`
`Instruments
`
`623.003 K-Wire gripper
`
`698.100 retractor 3 Blade Frame
`
`632.102 retractor 2 Blade Frame
`
`632.150 10mm Socket Driver
`
`698.250 hook and latch Driver
`
`675.403
`
`Flouro Modulator
`
`675.404
`
`incision locator
`
`675.513 8” Suction
`
`675.800 radiolucent initial Dilator holder
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`698.205 cannula a
`
`698.210 cannula B
`
`698.215 cannula c
`
`Qty
`
`Retractor Blades
`
`Qty
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
`698.476 Blade, Posterior, 170mm
`
`698.510 Blade, cc, 40mm
`
`698.512 Blade, cc, 50mm
`
`698.514 Blade, cc, 60mm
`
`698.516 Blade, cc, 70mm
`
`698.518 Blade, cc, 80mm
`
`698.520 Blade, cc, 90mm
`
`698.522 Blade, cc, 100mm
`
`698.524 Blade, cc, 110mm
`
`698.526 Blade, cc, 120mm
`
`698.528 Blade, cc, 130mm
`
`698.530 Blade, cc, 140mm
`
`698.532 Blade, cc, 150mm
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
`698.534 Blade, cc, 160mm
`
`698.536 Blade, cc, 170mm
`
`Disposables
`
`632.678S Bipolar Forceps, 10” Bayo, 1.0mm Tip
`
`698.600S MarS™3V Disposable Kit
`
`698.300S lengthening Shim
`
`698.305S Widening Shim
`
`698.310S Docking Pin, 10mm
`
`698.315S Docking Pin, 20mm
`
`698.325S Disc Shim, aluminum
`
`698.326S Disc Shim, Stainless Steel
`
` 2
`
` 2
`
`
`
` 1
`
` 1
`
` 2
`
` 2
`
` 2
`
` 2
`
` 1
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`698.220 cannula D
`
`698.230
`
`Frame handle
`
`698.240
`
`Shim Tool, cc
`
`698.260 Docking Pin Tool
`
`698.330 Disc Shim Tool
`
`698.350 Docking Pin Sleeve
`
`19
`
`Retractor Blades
`
`698.450 Blade, Posterior, 40mm
`
`698.452 Blade, Posterior, 50mm
`
`698.454 Blade, Posterior, 60mm
`
`698.456 Blade, Posterior, 70mm
`
`698.458 Blade, Posterior, 80mm
`
`698.460 Blade, Posterior, 90mm
`
`698.462 Blade, Posterior, 100mm
`
`698.464 Blade, Posterior, 110mm
`
`698.466 Blade, Posterior, 120mm
`
`698.468 Blade, Posterior, 130mm
`
`698.470 Blade, Posterior, 140mm
`
`698.472 Blade, Posterior, 150mm
`
`698.474 Blade, Posterior, 160mm
`
` 1
`
` 1
`
` 1
`
` 1
`
` 4
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
` 2
`
`Items highlighted in gray are additionally available.
`
`LLIF Procedure | 33
`
`Exhibit Y
`Page 255
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10234 Page 37 of
`65
`
`mars™ Instrument II set
`
`9 1
`
`0
`
`11
`
`12
`
`13
`
`14
`
`15
`
`23
`
`1
`
`6
`
`7
`
`8
`
`20
`
`17
`
`21
`
`25
`
`16
`
`18
`
`19
`
`3 4
`
`22
`
`
`
`34 | 34 |
`
`Exhibit Y
`Page 256
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10235 Page 38 of
`65
`
`mars™ Instrument II set 932.902
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`Instruments
`
`632.300 Fiber-Optic cord
`
`632.305 adapter, acMi
`
`632.306 adapter, Wolf
`
`632.307 adapter, Olympus
`
`632.308 adapter, Storz
`
`632.390 Port lock, 19mm
`
`632.391 Port lock, 22mm
`
`632.392 Port lock, 26mm
`
`632.401 2mm cannula
`
`632.402 5mm cannula
`
`632.403 8mm cannula
`
`632.404 12mm cannula
`
`632.405 15mm cannula
`
`632.406 18mm cannula
`
`632.407 22mm cannula
`
`632.408 26mm Port Mount
`
`632.409 26mm Port Positioner
`
`632.410 22mm Port Mount
`
`632.411 22mm Port Positioner
`
`632.412 19mm Port Mount
`
`632.413 19mm Port Positioner
`
`632.500 Table clamp
`
`632.750 articulating arm assembly
`
`932.002 MarS™ instrument ii graphic case
`
`Qty
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
` 1
`
`Items highlighted in gray are additionally available.
`
`LLIF Procedure | 35
`
`Exhibit Y
`Page 257
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10236 Page 39 of
`65
`
`anterIor dIsC PreP I Instrument set
`
`24
`
`24
`
`6
`
`2
`
`7
`
`3
`
`1
`
`28
`
`8
`
`9
`
`10
`
`18
`
`20
`
`22
`
`12
`
`14
`
`16
`
`19
`
`21
`
`11
`
`13
`
`15
`
`17
`
`28
`
`4
`
`5
`
`25
`
`23
`
`27
`
`26
`
`
`
`36 | 36 |
`
`Exhibit Y
`Page 258
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 77-58 Filed 06/14/18 PageID.10237 Page 40 of
`65
`
`anterior disc Prep I Instrument set 925.901
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Instrumen