Medtronic G3001015 Instructions for Use

ZEVO™ ANTERIOR CERVICAL PLATE

M708348B389E Rev. A

SYSTEM

2014-12-03

IMPORTANT INFORMATION ON THE ZEVO™ ANTERIOR CERVICAL PLATE SYSTEM

PURPOSE

The ZEVO™ Anterior Cervical Plate System implant components are temporary implants intended for anterior interbody screw
fixation of the cervical spine during the development of a cervical spinal fusion. The implantation of the ZEVO™

Plate System is via an anterior surgical approach.

DESCRIPTION

The ZEVO™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting
bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The ZEVO™ Plates include anti-

migration caps that cover the heads of the bone screws to reduce the potential for screw back-out. The anti-migration caps are
shipped pre-assembled to the plate. The implants are supplied both sterile and non-sterile.

The ZEVO™ Anterior Cervical Plate System implant components are made from titanium alloy, with plates having
subcomponents manufactured from Nitinol-NiTi. Stainless steel and titanium implant components must not be used together in a
construct.

Do not use ZEVO™ Anterior Cervical Plate System components with components from any other system or manufacturer. No
warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded.

Anterior Cervical

INDICATIONS

The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is
indicated for use in the temporary stabilization of the anterior spine during the development of cervical 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) pseudarthrosis, and/or 6) failed previous fusions.

NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or

lumbar spine.

CONTRAINDICATIONS

The ZEVO™ Anterior Cervical Plate 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 needing a bone graft and fusion or where fracture healing is not required.
▪ Any case not described in the Indications.
▪ Any medical or surgical condition which would preclude the potential 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 the post-operative instructions.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ Infection local to the operative site.
▪ Morbid obesity.
▪ Mental illness.
▪ Pregnancy.

▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this

condition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or the quality of the bone
graft.

▪ Signs of local inflammation.
▪ Suspected or documented metal allergy or intolerance.

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.

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:

▪ Atelectasis, ileus, gastritis, herniated nucleus pulposus, and/or retropulsed graft.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Bursitis and tissue damage caused by improper positioning and placement of implants or instruments.
▪ 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, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Dural tears.
▪ Dysphagia.
▪ Early or late loosening of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, staining, tumor

formation, and/or auto-immune disease.

▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone and/or bone graft or bone graft harvest site

at, above, and/or below the level of surgery.

▪ Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound

dehiscence, or damage to blood vessels.

▪ Inability to perform the activities of daily living.
▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Infection.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia,

paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, or tingling
sensation.

▪ Loss of spinal mobility or function.
▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, and/or pain.

▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.

Note: Additional surgery may be necessary to correct some of these anticipated adverse events.

WARNINGS AND PRECAUTIONS

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. The ZEVO™ Anterior Cervical Plate System is only a temporary

implant 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 ZEVO™ Anterior Cervical Plate System is utilized. Use of
this product without a bone graft or in cases that develop into a non-union will not be successful. This spinal implant cannot
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 planning and operating procedures including knowledge of surgical techniques,
proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of

the ZEVO™ Anterior Cervical Plate System by the surgeon. 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 and/or other drug abuse