Medtronic G7743511 Instructions for Use

DIVERGENCE™ Anterior Cervical Fusion System

2014-08-25

AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd

97 Waterloo Rd
North Ryde, NSW 2113
Australia

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (in U.S.A)
Telephone: [phone] (Outside U.S.A)
Fax: [phone]

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

M708348B382E Rev. A

IMPORTANT INFORMATION ON THE DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

PURPOSE

The DIVERGENCE™ Anterior Cervical 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 who has
been instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The DIVERGENCE™ Anterior Cervical Fusion System consists of plates, bone screws, and interbody cages.
The DIVERGENCE™ anterior cervical plates and bone screws are available in a broad range of size offerings that are intended for anterior screw fixation

intended for stabilization use 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 cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made

from titanium alloy and are provided sterile.
The DIVERGENCE™ anterior cervical cages are available in various widths and heights that can be inserted between two cervical vertebral bodies to give

support and correction during cervical interbody fusion surgeries. 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 graft and must be used with supplemental fixation. The cages are
manufactured from medical grade Polyetheretherketone (PEEK) with titanium alloy wire 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™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. 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 spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by
neck 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) pseudoarthrosis; and/or 6) failed previous fusions.
The DIVERGENCE™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients

with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or
myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord
compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The

DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with autogenous bone graft and/or
allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™ components can be used only to treat cervical disc disease.

CONTRAINDICATIONS

The DIVERGENCE™ Anterior Cervical 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 required 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.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.

Contraindications of this device are consistent with those of other spinal systems.
NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only.
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, dysphagia.
▪ 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 of the autograft, 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 or

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 anticipated 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™ Anterior Cervical 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 be used 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™ Anterior Cervical Fusion System is utilized. Use of a plate device without bone graft material may not be successful.
Use of the DIVERGENCE™ Anterior Cervical Fusion System cage component in cervical interbody fusion procedures without autogenous bone graft and/or

allogenic bone graft comprised of cancellous and/or corticocancellous 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 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, 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™ Anterior Cervical 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.

▪ Further information on the use of this system will be made available on request.
▪ 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 to be assembled for the case should be determined prior to beginning the 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 available applicable surgical technique manual should be carefully followed.
▪ The DIVERGENCE
▪ 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, autograft and/or allogenic bone graft must be used in all cervical 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 after finishing to make sure 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.

™

anterior cervical plate is not designed to be contoured.

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

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.

™

Anterior Cervical Fusion System plate components are temporary internal fixation devices. Internal fixation devices are designed to

▪ 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.

PACKAGING

Devices may be supplied in a sterile form. Packages for each of the components 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

The DIVERGENCE™ Anterior Cervical Fusion System implants are supplied in a sterile form. Never autoclave or in any other way attempt to re-sterilize or
re-use the DIVERGENCE™ Anterior Cervical Fusion System implants.

MRI INFORMATION

The DIVERGENCE™ Anterior Cervical Fusion System has not been evaluated for safety, compatibility, heating, or migration in the MR environment.

PRODUCT COMPLAINTS

Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction in the
product quality, identity, durability, reliability, safety, effectiveness, and/or performance should notify the distributor or Medtronic. Further, if any of the
implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any of its performance specifications or otherwise does not perform as
intended), or is suspected of doing so, the distributor should be notified immediately. If any Medtronic product ever malfunctions and may have caused or
contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing
a complaint, provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint, and notification of whether or
not a written report from the distributor is requested.

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.

©2014 Medtronic Sofamor Danek USA, Inc. All rights reserved.

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

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

Do not re-use

Batch code

Manufacturer

Catalogue number

For US audiences only

The device complies with European Directive MDD 93/42/EEC

Sterilized using irradiation

Use-by date

Consult instructions for use