AVILATM INTERBODY FUSION DEVICE. A complete anterior and oblique titanium alloy Cage system adapted to patient's lordosis needs.

Transcription

1 AVILATM INTERBODY FUSION DEVICE A complete anterior and oblique titanium alloy Cage system adapted to patient's lordosis needs.

2 AVILA TM INTERBODY FUSION DEVICE A complete anterior and oblique titanium alloy Cage system adapted to patient's lordosis needs. TABLE OF CONTENTS Introduction 3 Instruments 4 Cage 6 AVILA Cage features 6 AVILA -A 8 Exposure 8 Disc preparation 8 Distraction and trialing 9 Cage insertion 12 AVILA -O 16 Exposure 16 Disc preparation 16 Distraction and trialing 17 Cage insertion 18 AVILA Family 19 Stabilisation 19 Cage removal 19 Disassembly instructions for AVILA Inserter 19 Cage information 20 Sets ordering information 21 Important information on the AVILA Interbody Fusion Device 22

3 INTRODUCTION The AVILA Interbody Fusion Device is the system of choice to enable anterior and oblique Interbody Fusion approaches from L2 to S1. Created with simple instrumentation, compact trays, the AVILA Interbody Fusion Device provides the surgeon a wide range of anterior and oblique Cages. The AVILA Cages are engineered to maximize their contact with the vertebra, aiming to reduce the risk of subsidence and to facilitate fusion. This Cage offering provides a variety of lordotic angulations (from 8 to 24 ) to adapt to the patient's anatomy and help with the restoration of lumbar lordosis. The AVILA Interbody Fusion Device provides two distinct types of Cages: the AVILA -A and the AVILA -O. The AVILA -A system allows for a straight anterior approach (ALIF) of the lumbar spine (such as for the L5-S1 level). It may also be inserted with an offset angle of 25 /-25. This oblique approach aims to preserve the anterior longitudinal ligament and reduce the mobilization of the patient's vasculature. The AVILA -O system is dedicated to an oblique approach (OLIF). The Cage is inserted with a 30 angle allowing for psoas-preserving access while avoiding obstacles associated with traditional anterior approach. SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 3

4 INSTRUMENTS INSERTER INNER SHAFT SHIM DISTRACTORS PUSHER INSERTER OUTER SLEEVE 4 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

5 AVILA -O TRIALS GRAFT LOADER AVILA -A TRIALS POSITIONING GUIDE SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 5

6 CAGE AVILA TM CAGE FEATURES Made in Titanium Alloy (TI6Al4V ELI). Dual convexity surface on the top plus a flat surface on the bottom to provide an intimate fit with vertebra endplates, maximizing cage-endplate contact surface and the primary stabilization. (Figure 1) Beams to aid holding bone graft in place and improve the cage-endplate contact surface. (Figure 2) Anti-back out teeth on both surfaces to grip the endplate for expulsion resistance. (Figure 3) Large lateral window to assess fusion. (Figure 3) Figure 1 Figure 2 Figure 3 6 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

7 The AVILA Interbody Fusion Device provides two distinct types of Cages to enable anterior and oblique Interbody Fusion approaches from L2 to S1: the AVILA -A and the AVILA -O. AVILA -A Cage dimensions Posterior heights: 6, 8, 10 & 12 mm 5 lordotic angulations Footprints Dimensions (Width x Length) Length Small (S) Medium (M) Large (L) 32 x 23 mm 37 x 27 mm 42 x 30 mm Width insertion options: Straight +/- 25 o angle AVILA -O Cage dimensions AVILA -O is built upon AVILA -A Cage design with a cut along the 30 insertion angle minimizing the retraction of the vascular elements during its insertion. Footprints Dimensions (Width x Length) Length Posterior heights: 6, 8 &10 mm 2 lordotic angulations 12 8 Small (S) Medium (M) Large (L) 24 x 22.5 mm 27 x 26.5 mm 30 x 29.5 mm Width Insertion with a 30 o angle For additional information on the AVILA -A and AVILA -O set configuration, Cage anterior height and bone graft volume (cc), refer to page of this surgical technique. SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 7

8 AVILA TM -A EXPOSURE Anterior lumbar spine may be approached through either a transperitoneal, a retroperitoneal or a more laterally positioned retroperitoneal exposure. The latter is described in the OLIF51 Surgical Technique. The amount of great vessel release and retraction should be limited to that required for insertion of the instruments and the construct. To help with the surgical demands of antero-lateral approaches (L2-S1), the AVILA -A device may be inserted straight or with a 25 off-set angle. To enhance muscle retraction, the ENDO-RING surgical retraction system may be used. (Figure 4) The ENDO-RING surgical retraction system allows direct visualisation and stable retraction for less invasive spine surgery, eliminating the need for large handheld retractors. Alternatively the 51 Access System may be used. (Figure 5) 51 Access System provides unconstrained retractors for an additional freedom of movement during the surgery, while ensuring the required protection to patient's anatomy. DISC PREPARATION Once the level has been exposed and the great vessels have been mobilised the midline of the intervertebral disc should be identified and marked. Mark the centerline location on the inferior and superior vertebral bodies. (Figure 6) Perform discectomy removing a sufficient amount of disc and anterior longitudinal ligament for the AVILA Cage to fit properly. Use the required instruments to adequately prepare the endplates, removing the superficial layers of the cartilaginous endplates and enhancing vascular supply to the fusion site. Figure 4 ENDO-RING surgical retraction system Figure 5 51 Access System Figure 6 Location of the centerline of the inferior and superior vertebral bodies NOTE Anterior osteophytes adjacent to the interbody must be removed when anterior stabilisation with plate system such as PYRAMID +4 Anterior Lumbar Plate System is planned. 8 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

9 DISTRACTION AND TRIALING Distraction of the disc space may be required for restoration of disc height, opening of the intervertebral foramen and construct stability. A range of Trials is available in the AVILA -A set to assess vertebra footprint, and distract the disc space until the required height and lordosis angulation is achieved. Assemble the Inserter by inserting the Inserter Inner Shaft into the Inserter Outer Sleeve until the threads contact. (Figure 7a) Turn the wheel of the Inserter Inner Shaft clockwise until the shaft slides freely into the Inserter Outer Sleeve. (Figure 7b) Ensure the wheel can rest flush against the handle, and that there is no space. (Figure 7c) Figure 7 Assembling of the Inserter Figure 7a Figure 7b Figure 7c SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 9

10 DISTRACTION AND TRIALING Depending upon the chosen surgical approach, the Trials can be attached to the Inserter with a straight or with a 25 angle. (Figure 8) Defining Cage footprint: From the AVILA -A Trial rack select small, medium or large 6 mm AVILA -A Trial. (Figure 9) Turn the wheel clockwise to thread the tip of the Inserter Inner Shaft into the threaded hole of the appropriate AVILA -A Trial until it is firmly hand-tightened. Ensure that the slots and tabs are aligned. (Figure 10) Figure 9 Selection of the narrow 6mm Avila-A trial (illustrated with a straight connection to the inserter) Figure 10 No clearance between the Inserter and the AVILA -A Trial or Cage Figure 8 Straight and 25 off-set angle Trial insertion 10 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

11 Insert the selected AVILA -A Trial into the disc space. Use fluoroscopy to assess the required footprint and Trial positioning within the disc space. To change for another footprint disconnect the attached AVILA -A Trial from the Inserter, turning the wheel counter clockwise. NOTE It is recommended to use the largest footprint possible. This will ensure maximum stability for the Cage and limit subsidence. Unlike the Cage, the AVILA -A Trials do not feature the dual convex surface on the top. Figure 11 Use Shim Distractor to hold the disc space distraction Defining Cage height and Lordosis: Once the footprint size is selected, sequentially insert Trials of increasing height and lordosis until a tight fit in the disc space is achieved. Shim Distractors may be used to hold the disc space distraction before a larger sized Trial or the chosen Cage is inserted. (Figure 11) Select Shim Distractor (6mm, 8mm, 10mm or 12mm) to match the in-placetrial posterior height. The Shim Distractors feature 3 holes. The distances between the tip of the instrument and the holes correspond to the lengths of the small, medium and large AVILA -A footprints. (Figure 12) S M L Figure 12 Lateral view of the Shim Distractor SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 11

12 CAGE INSERTION In accordance with the chosen surgical approach, the Cage can be inserted with a straight or with a 25 angle. Figure 12 Selection of the Cage from the AVILA -A rack From the AVILA -A Cage rack, select the chosen Cage and attach it to the Inserter (Figure 12) as described for the Trials in the "Distraction and Trialing" section. The AVILA Interbody Fusion Device is indicated to be used with all bone graft substitutes including osteoinductive protein such as rhbmp. Refer to your local sales representative for more information on the Medtronic bone graft substitute options. CERAMIC ALLOGRAFT rhbmp Composition: Calcium phosphates, calcium sulfate and bioglass used alone or in combination. Mode of action: Provide an osteoconductive scaffold for bone formation. Composition: Donor bone and tissue. Mode of action: Cortical and cancellous bone chips are strictly osteoconductive. DBMs may be osteoinductive. Composition: Recombinant human bone morphogenetic protein + carrier. Mode of action: An osteoinductive protein that binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into bone forming cells. 12 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

13 Sit the Cage on the Graft loader to pack bone graft and/or bone graft substitute into the cage. (Figure 13) Figure 13 Loading of bone graft and bone graft substitute in the Cage Figure 14 Straight and 25 off-set AVILA -A Cage insertion Impact the Cage into the disc space aligning the middle of the Cage with the marked midline of the disc space. (Figure 14) SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 13

14 CAGE INSERTION While inserting the Cage, ensure that the Cage dual convexity surface is facing the patient's head. (Figure16) Arrows show the Cage cranial direction. (Figure 17) IMPORTANT The AVILA -A Cage is to be used with supplemental fixation instrumentation (refer to the "Stabilisation" section page 19). For patients requiring a 20 or 24 angulation Cage it is mandatory to use an anterior plating fixation at the instrumented level. NOTE The maximum stability of the Cage is reached when surfaces of the Cage are in contact with the superior and the inferior endplates. Use fluoroscopy to monitor the antero-posterior positioning of the Cage in the disc space. (Figure 16) NOTE The Cage features holes on the anterior and posterior walls. Aligning them under fluoroscopy helps in getting a true A/P view of the Cage and ultimately facilitates the device placement within the disc space. (Figure 18) Figure 16 Cage double convexity faces the patient's head Figure 17 Arrows on the AVILA -A Cage show cranial direction Figure 18 Alignment of Anterior and Posterior holes 14 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

15 Release the Cage by turning anticlockwise the wheel of the Inserter. If necessary, final placement of the Cage position can be obtained using the Pusher. (Figure 19a, 19b) Figure 19a Repositioning of the Cage under fluoroscopy Figure 19b SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 15

16 AVILA TM -O EXPOSURE The AVILA -O interbody device is used for oblique lateral interbody fusion procedure from L2 to L5 (OLIF25 ). This technique allows for psoaspreserving access while avoiding obstacles associated with traditional anterior approach. For patient positioning, localisation, exposure and retractor placement refer to the OLIF25 Surgical Technique. To enhance muscle retraction, the MAST QUADRANT Lateral Retractor System may be used, providing direct visualisation of the anatomy in a 360 field of view. (Figure 20) DISC PREPARATION Determine the midline as previously described in the AVILA -A "Disc preparation" section (page 8). Perform discectomy removing enough disc material to fit the Cage. Use the required instruments to adequately prepare the endplates, removing the superficial layers of the cartilaginous endplates and enhancing vascular supply to the fusion site. Use the Positioning Guide to mark the 30 entry point of the AVILA -O Trials and AVILA -O Cages. Insert the Positioning Guide aligning the left corner projection of the instrument with the midline of the vertebra. (Figure 21) Use fluoroscopy to monitor the antero-posterior advancement of the Positioning Guide. (Figure 22) The Positioning Guide features 3 traversing holes that aid adjusting the orientation of the instrument. Under true lateral fluoroscopy adjust the instrument so the 3 holes can be clearly seen. (Figure 22) This ensures the correct placement of the Positioning Guide. The grooved line indicates the AVILA -O Cage entry point. Mark the location on the vertebral bodies. (Figure 21) Figure 22 Positioning Guide's three lateral holes under lateral fluoroscopy Midline mark 300 mark AVILA -O entry point S M L Figure 20 MAST QUADRANT Lateral Retractor System Figure 21 Positioning Guide with midline and 30 entry point marks NOTE With the Positioning Guide aligned with the posterior wall, the lateral holes can provide an indication on the required AVILA -O footprint. (Figure 22) 16 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

17 DISTRACTION AND TRIALING Refer to the AVILA -A (page 9) for the assembly instructions of the Inserter. Defining Cage footprint: From the AVILA -O Trial rack, select small, medium or large 6 mm AVILA -O Trial. (Figure 23) Turn the wheel clockwise to thread the tip of the Inserter Inner Shaft into the threaded hole of the appropriate AVILA -O Trial until it is firmly hand-tightened. Ensure that the slots and tabs are aligned. (Figure 24) Insert the selected AVILA -O Trial into the disc space aligning the 30 entry point mark with the slot-tab line that makes the AVILA -O trial with the Inserter. (Figure 24) Use fluoroscopy to assess the footprint and Trial positioning within the disc space. To change for another footprint, disconnect the attached AVILA -O Trial from the Inserter, turning the wheel counter clockwise. Defining Cage height and Lordosis: As per the AVILA -A technique, use incrementally higher and/or more angulated AVILA -O Trials until a tight fit in the disc space is achieved. Use the largest Trial size possible to ensure maximum stability. The Shim distractors (6mm, 8mm, 10 mm and 12mm) may be used to maintain interbody distraction before a larger sized AVILA -O Trial or the chosen AVILA -O Cage is inserted. Figure 23 Selection of the Trial from the AVILA -O rack Figure 24 No clearance between the Inserter and the AVILA -O Trial or Cage NOTE In contrast to AVILA -A the holes on the Shim Distractor do not have any function for the AVILA -O system. SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 17

18 CAGE INSERTION From the AVILA -O Cage rack, select the chosen Cage and attach it to the Inserter as described in the AVILA -O "Distraction and Trialing" section (page 17). Pack the AVILA -O Cage with bone graft and/or bone graft substitute using the Graft loader (refer to page 12 for additional information on the bone graft substitute options). Insert the AVILA -O Cage into the disc space aligning the 30 entry point mark with the slot-tab line that makes the AVILA -O Cage with Inserter. (Figure 26a, 26b) While inserting the Cage, ensure that the Cage dual convexity surface is facing the patient's head. Arrows show the Cage cranial direction. (Figure 27) The maximum stability of the Cage is reached when surfaces of the Cage are in contact with the superior and the inferior endplates. Use fluoroscopy to monitor the antero-posterior positioning of the Cage in the disc space. Release the Cage by turning anticlockwise the wheel of the Inserter. If necessary, final placement of the Cage position can be obtained using the Pusher as presented in the AVILA -A section (page 14). IMPORTANT The AVILA -O Cage is to be used with supplemental fixation instrumentation (refer to the "Stabilisation" page 19). Figure 26a Implantation and Cage positioning of the AVILA -O Cage Figure 27 Arrows on the AVILA -O Cage show cranial direction Figure 26b AVILA -O Cage position in axial view 18 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

19 AVILA TM FAMILY STABILISATION The AVILA Interbody Fusion Device is to be used with supplemental fixation instrumentation. Select anterior and/or posterior stabilization such as the PYRAMID +4 Anterior Lumbar Plate System, CD HORIZON SOLERA SEXTANT Percutaneous Rod System, CD HORIZON VOYAGER Mini open Rod System or CD HORIZON LONGITUDE II System. (Figure 28) IMPORTANT For Patients requiring a 20 or 24 angulation Cage, it is mandatory to use an anterior plating fixation at the instrumented level. CAGE REMOVAL If it becomes necessary to remove the Cage, attach it to the Inserter to extract it. If bone has grown through the Cage, it may be necessary to use an osteotome to cut bone between the vertebra end plates and the Cage. DISASSEMBLY INSTRUCTIONS FOR AVILA INSERTER Grip the handle of the Inserter Outer Sleeve and pull the Inserter Inner Shaft until resistance is felt. Turn the wheel of the Inserter Inner Shaft counter clockwise until it can slide freely out of the Inserter Outer Sleeve. Figure 28 Supplemental fixation options PYRAMID +4 Anterior Lumbar Plate System CD HORIZON LONGITUDE II CD HORIZON SOLERA SEXTANT Percutaneous Rod System CD HORIZON VOYAGER TM Mini open Rod System SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 19

20 CAGE INFORMATION AVILA TM -A CFN DESCRIPTION SIZE (mm) Width x length LORDOSIS ANGLE (0) POSTERIOR HEIGHT (mm) ANTERIOR HEIGHT (mm) GRAFT VOLUME (cc) Implant Small 8 6mm 32 x Implant Small 8 8mm 32 x Implant Small 8 10mm 32 x Implant Small 12 6mm 32 x Implant Small 12 8mm 32 x Implant Small 16 6mm 32 x Implant Medium 8 6mm 37 x Implant Medium 8 8mm 37 x Implant Medium 8 10mm 37 x Implant Medium 8 12mm 37 x Implant Medium 12 6mm 37 x Implant Medium 12 8mm 37 x Implant Medium 12 10mm 37 x Implant Medium 12 12mm 37 x Implant Medium 16 6mm 37 x Implant Medium 16 8mm 37 x Implant Medium 16 10mm 37 x Implant Medium 20 6mm 37 x Implant Medium 20 8mm 37 x Implant Medium 24 6mm 37 x Implant Large 8 6mm 42 x Implant Large 8 8mm 42 x Implant Large 12 6mm 42 x Implant Large 12 8mm 42 x Implant Large 16 6mm 42 x AVILA TM -O CFN DESCRIPTION SIZE (mm) Width x length LORDOSIS ANGLE (0) POSTERIOR HEIGHT (mm) ANTERIOR HEIGHT (mm) GRAFT VOLUME (cc) Implant Small 8 6mm 24 x Implant Small 8 8mm 24 x Implant Small 8 10mm 24 x Implant Small 12 6mm 24 x Implant Small 12 8mm 24 x Implant Medium 8 6mm 27 x Implant Medium 8 8mm 27 x Implant Medium 8 10mm 27 x Implant Medium 12 6mm 27 x Implant Medium 12 8mm 27 x Implant Medium 12 10mm 27 x Implant Large 8 6mm 30 x Implant Large 8 8mm 30 x Implant Large 12 6mm 30 x Implant Large 12 8mm 30 x AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

21 SETS ORDERING INFORMATION SPS01724 AVILA TM -A INSTRUMENT SET CFN DESCRIPTION QTY Inserter Inner shaft Inserter Outer sleeve Pusher Shim distractor Shim distractor Graft loader Trial Small 8 6mm Trial Small 8 8mm Trial Small 8 10mm Trial Small 12 6mm Trial Small 12 8mm Trial Small 16 6mm Trial Medium 8 6mm Trial Medium 8 8mm Trial Medium 8 10mm Trial Medium 8 12mm Trial Medium 12 6mm Trial Medium 12 8mm Trial Medium 12 10mm Trial Medium 12 12mm Trial Medium 16 6mm Trial Medium 16 8mm Trial Medium 16 10mm Trial Medium 20 6mm Trial Medium 20 8mm Trial Medium 24 6mm Trial Large 8 6mm Trial Large 8 8mm Trial Large 12 6mm Trial Large 12 8mm Trial Large 16 6mm Tray Instrument Set Generic Lid 1 SPS01725 AVILA TM -A CAGE SET CFN DESCRIPTION QTY Implant Small 8 6mm Implant Small 8 8mm Implant Small 8 10mm Implant Small 12 6mm Implant Small 12 8mm Implant Small 16 6mm Implant Medium 8 6mm Implant Medium 8 8mm Implant Medium 8 10mm Implant Medium 8 12mm Implant Medium 12 6mm Implant Medium 12 8mm Implant Medium 12 10mm Implant Medium 12 12mm Implant Medium 16 6mm Implant Medium 16 8mm Implant Medium 16 10mm Implant Medium 20 6mm Implant Medium 20 8mm Implant Medium 24 6mm Implant Large 8 6mm Implant Large 8 8mm Implant Large 12 6mm Implant Large 12 8mm Implant Large 16 6mm Tray Implant Set Lid Implant Set 1 SPS01726 AVILA TM -O CAGE AND INSTRUMENT SET CFN DESCRIPTION QTY Inserter Inner shaft Inserter Outer sleeve Pusher Shim Distractor Shim Distractor Positioning Guide Graft Loader Trial Small 8 6mm Trial Small 8 8mm Trial Small 8 10mm Trial Small 12 6mm Trial Small 12 8mm Trial Medium 8 6mm Trial Medium 8 8mm Trial Medium 8 10mm Trial Medium 12 6mm Trial Medium 12 8mm Trial Medium 12 10mm Trial Large 8 6mm Trial Large 8 8mm Trial Large 12 6mm Trial Large 12 8mm Implant Small 8 6mm Implant Small 8 8mm Implant Small 8 10mm Implant Small 12 6mm Implant Small 12 8mm Implant Medium 8 6mm Implant Medium 8 8mm Implant Medium 8 10mm Implant Medium 12 6mm Implant Medium 12 8mm Implant Medium 12 10mm Implant Large 8 6mm Implant Large 8 8mm Implant Large 12 6mm Implant Large 12 8mm Tray Instrument/Implant Set Generic Lid 1 SURGICAL TECHNIQUE AVILA TM INTERBODY FUSION DEVICE 21

22 IMPORTANT INFORMATION ON THE AVILA INTERBODY FUSION DEVICE PURPOSE This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the implant's material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations. This device is manufactured in medical grade titanium alloy (titanium-6aluminum-4vanadium ELI). DESCRIPTION The AVILA Interbody Fusion Device consists of cages of various widths, heights, and angulations which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or bone graft substitute. The AVILA Interbody Fusion Device is to be used with supplemental fixation instrumentation. The AVILA Interbody Fusion Device consists of a variety of anterior and oblique cages. The anterior cages are offered in a variety of sizes ranging from 6mm to 14mm in posterior height, 23mm to 30mm in length, and between 32mm and 42mm in width. An array of options is provided for the anterior cages spanning from 8 degrees to 24 degrees of angulation to adapt to the patient's lordosis. The oblique cages are offered in a variety of sizes ranging from 6mm to 14mm in posterior height, 22.5mm to 29.5mm in length, and between 24mm and 30mm in width. Two lordosis options are provided for the oblique cages 8 and 12 degrees of angulation. These titanium alloy (titanium-6aluminum-4vanadium ELI) devices are designed with teeth across both the superior double convex surface and inferior flat surface to allow the implant to grip the vertebral endplates, thus improving the resistance to expulsion. Additionally, this device has a space for packing autogenous bone graft and/or bone graft substitute. This space enables a large bone graft surface area to be in contact with the vertebra endplates. The device also has lateral windows for visibility of the fusion. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. INDICATIONS The AVILA Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/ or bone graft substitute in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. CONTRAINDICATIONS This device is not intended for cervical and thoracic spine use. Contraindications include, but are not limited to: Active infectious process or significant risk of infection (immunocompromise) Signs of local inflammation Fever or leukocytosis Morbid obesity Pregnancy Mental illness Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count Suspected or documented metal allergy or intolerance Any case not needing an autogenous bone graft and/or bone graft substitute and fusion Any case not described in the indications Any patient unwilling to cooperate with postoperative instructions Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery Pediatric cases, nor where the patient still has general skeletal growth Spondylolisthesis unable to be reduced to Grade 1 Any case where the implant components selected for use would be too large or too small to achieve a successful result Any case that requires the mixing of metals from two different components or systems Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance Prior fusion at the level to be treated POTENTIAL ADVERSE EVENTS Adverse events may occur when the device is used either with or without associated instrumentation. The risk of adverse events as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include but are not limited to: Implant migration Breakage of the device(s) Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice or general corrosion) including metallosis, staining, tumor formation, or autoimmune disease Pressure on the surrounding tissues or organs Post-operative change in spinal curvature, loss of correction, height, or reduction Infection Bone fracture or stress shielding at, above, or below the level of surgery Non-union (or pseudarthrosis), delayed union, or mal-union Loss of neurological function (e.g., sensory or motor) including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, or visual deficits Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of serious injury Cerebral spinal fluid leakage Haemorrhage of blood vessels and/or hematomas Discitis, arachnoiditis, and/or other types of inflammation Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus Graft donor site complications including pain, fracture, or wound healing problems Inability to perform the activities of daily living Early or late loosening or movement of the device(s) Urinary retention or loss of bladder control or other types of urological system compromise Scar formation possibly causing neurological compromise or compression around nerves and/or pain. Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery Retropulsed graft Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery Loss of or increase in spinal mobility or function Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.) Change in mental status Death WARNINGS AND PRECAUTIONS A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. This device system is not intended to be the sole means of spinal support. Use of this product without autogenous bone graft and/or bone graft substitute or in cases that do not develop a union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, or breakage of the device(s) will eventually occur. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol/drug abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality or nerve paralysis are also poor candidates for spine fusion. For patients requiring devices with 20 and/or 24 angulation, the use of an anterior plate fixation at instrumented levels is mandatory. Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery. A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death. Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied and designated by Medtronic. In the interest of patient safety, it is recommended that Medtronic implants are not used with devices from any other source. NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include: Severe bone resorption Osteomalacia Severe osteoporosis 22 AVILA TM INTERBODY FUSION DEVICE SURGICAL TECHNIQUE

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24 Medtronic International Trading Sàrl Case Postale Route du Molliau 31 CH-1131 Tolochenaz Tel. +41 (0) Fax +41 (0) Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN (901) (800) Customer Service: (800) The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient. Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information. UC EE, EMO Medtronic All Rights Reserved. Printed in Europe. NOT FOR DISTRIBUTION IN THE U.S. OR ITS TERRITORIES