INDICATIONS, SAFETY, AND WARNINGS DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

PURPOSE

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and 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 instructed as to its mechanical and material applications and limitations. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone material, or INFUSE™ Bone Graft (as designated below with the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cages), to facilitate fusion.

DESCRIPTION

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plate and bone screws are made from titanium alloy and are provided sterile. Additionally, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cages may be used as supplemental fixation when used in conjunction with posterior fixation devices to treat deformity conditions in the thoracic and lumbar spine. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, or INFUSE™ Bone Graft (as designated below). The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

Medical grade titanium and medical grade PEEK may be used together. Never use titanium or titanium alloy implants 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 DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). 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. Additionally, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCE- L™ Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2)trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

Certain sizes of the Certain sizes of the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSE™ Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended for use with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine when used to treat DDD. Consult the labeling for the INFUSE™ Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with INFUSE™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE™ Bone Graft. DIVERGENCE-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSE™ Bone Graft.

CONTRAINDICATIONS

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System is not intended for posterior surgical implantation. Contraindications include, but are not limited to:

Any case needing to mix metals from different components.
Any case not described in the indications.
Any medical or surgical condition which would preclude the benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
Any patient unwilling to cooperate with postoperative instructions.
Any case not needing a bone graft and fusion or where fracture healing is not required.
Any time implant utilization would interfere with anatomical structures or expected physiological performance.
Fever or leukocytosis.
For interbody cage, patients with known hereditary or acquired bone friability or calcification problems.
For interbody cage, prior fusion at the level to be treated.
Infection local to the operative site and/or signs of local inflammation.
Mental illness.
Morbid obesity.
Pregnancy.
Spondylolisthesis unable to be reduced to Grade 1.
Suspected or documented allergy or intolerance to the component materials.

Nota bene: this device system is intended for Anterior/Oblique Lumbar intervertebral body fusions only when used to treat DDD. Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

Severe bone resorption.
Osteomalacia.
Severe osteoporosis.

Warning: this plate device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

POTENTIAL ADVERSE EVENTS

All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:

Bone loss or decrease in bone density, possibly caused by stress shielding.
Cessation of any potential growth of the operated portion of the spine.
Change in mental status.
Death.
Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
Disassembly, bending, and/or breakage of any or all of the components.
Disc disruption or degeneration at, above, or below the level of surgery.
Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
Early or late loosening of the components and implant migration.
For interbody cage, cauda equina syndrome.
For plate device, atelectasis, ileus, gastritis.
For plate device, pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain.
For plate device, bursitis.
Foreign body (allergic) reaction to the implants, debris, corrosion products including metallosis, staining, tumor formation, and/or autoimmune disease.
Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, or bone graft, or at the bone graft harvest site at, above, and/or below the level of surgery.
Gastrointestinal complications.
Graft donor site complications including pain, fracture, infection, or wound healing problems.
Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or cardiovascular system compromise.
Herniated nucleus pulposus and/or retropulsed graft.
Gastrointestinal and/or reproductive system compromise including sterility and loss of consortium.
Infection.
Loss of bowel and/or bladder control or other types of urological system compromise.
Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia, paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling sensation, sensory loss, and/or spasms.
Loss of spinal mobility or function and inability to perform the activities of daily living.
Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, arachnoiditis, and/or muscle loss.
Non-union (or pseudarthrosis), delayed union, and mal-union.
Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
Scar formation possibly causing neurological compromise around nerves and/or pain.
Subsidence of the interbody cage device into vertebral body(ies).
Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
Wound necrosis or wound dehiscence.

Note: additional surgery may be necessary to correct some of these potential adverse events.

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.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plate and bone screw components are only temporary implants used for the correction and stabilization of the spine. This system is also intended to augment the development of a spinal fusion by providing temporary stabilization. This device system is not intended to be the sole means of spinal support. Bone grafting must be part of the spinal fusion procedure in which the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System is utilized. Use of a plate device without bone graft material may not be successful.

Use of the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage component in lumbar interbody fusion procedures without bone graft may not be successful.

No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of the device(s) will eventually occur.

Preoperative and operating procedures including knowledge of surgical techniques, proper selection and placement of the implant, and good reduction are important considerations in the success of surgery. Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery. This system should not be used in any case not described in the indications.

Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of the instrumentation. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also not good candidates for spine fusion.

A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile packaged devices are never to be resterilized. Reuse, reprocessing, or re-sterilization 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.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.

Based on fatigue testing results, when using the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System cage, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of this system.

For US Audiences Only

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

IMPLANT SELECTION

The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure. Surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage, bending, or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the device prematurely.

PREOPERATIVE

Only patients that meet the criteria described in the indications should be selected.

Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided. Care should be used in the handling and storage of the implant components. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments. Since

mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to verify all parts and necessary instruments are present before the surgery begins. Different metal types should not be used together.

The type of construct assembled should be determined prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used. These devices are provided sterile. Additional sterile components should be available in case of an unexpected need.

INTRAOPERATIVE

The instructions in any applicable surgical technique manual should be carefully followed.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plate is not designed to be contoured.

At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.

Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel. To ensure proper fusion below and around the location of the instrumentation, autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone must be used in all lumbar interbody fusion procedures. The graft material is to be placed in the area to be fused and the graft material must extend from the upper to the lower vertebrae being fused.

Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat generated from the curing process may also cause neurologic damage and bone necrosis. Before closing the soft tissues, all bone screws should be seated onto the plate. Recheck the tightness of all screws to ensure none have loosened during the tightening of the other screws. Lock the anti-migration cap over the heads of the screws. Failure to do so may result in screw loosening. Caution: excessive torque on the threads may cause the threads to strip in the bone and may reduce fixation.

POSTOPERATIVE

The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important. Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the device components are complications which can occur as a result of excessive weight bearing or muscular activity. The risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.

To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone healing process.

Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. If a non-union develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System plate components are temporary internal fixation devices. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no functional purpose and should be removed. In most patients, removal is indicated because the implants

are not intended to transfer or support forces developed during normal activities. If the device is not removed following completion of its intended use, one or more of the following complications may occur: (1) corrosion with localized tissue reaction or pain; (2) migration of implant position possibly resulting in injury; (3) risk of additional injury from post- operative trauma; (4) bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) pain, discomfort, or abnormal sensations due to the presence of the device; (6) possible increased risk of infection; and (7) bone loss due to stress shielding.

While the surgeon must make the final decision on implant removal, it is the position of the Orthopedic Surgical Manufacturers Association that whenever possible and practical for the individual patient, bone fixation devices should be removed once their service as an aid to healing is accomplished, particularly in younger and more active patients. Any decision to remove the device should take into consideration the risk to the patient of a second surgical procedure and the difficulty of removal. Implant removal should be followed by adequate postoperative management to avoid fracture.

Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

MAGNETIC RESONANCE SAFETY

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

PACKAGING

Devices are supplied in a sterile form. Packages for each of the implants should be intact upon receipt. Once the seal on the sterile package has been broken, the product should not be re-sterilized. Damaged packages or products should not be used, and should be returned to Medtronic.

STERILIZATION

Devices are supplied in a sterile form. Never autoclave or in any other way attempt to re-sterilize or re-use the DIVERGENCE- L™ Anterior/Oblique Lumbar Fusion System implants.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, contact Medtronic.