Medtronic X4802421 Instructions for Use

VENTURE™ Anterior Cervical Plate

M708348B446E Rev. B

System

2017-06-27

IMPORTANT INFORMATION ON THE VENTURE™ ANTERIOR CERVICAL PLATE
SYSTEM

PURPOSE

The VENTURE™ Anterior Cervical Plate System 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 VENTURE™ Anterior
Cervical Plate System is via an anterior surgical approach.

DESCRIPTION

The VENTURE™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is provided by the
insertion of bone screws through the openings at each end of the plate into the vertebral bodies of the cervical spine.
Associated instruments are also available to facilitate the implantation of the device.

The VENTURE™ Anterior Cervical Plate System implant components are made from titanium alloy, with certain
subcomponents manufactured from shape memory alloys (Nitinol – NiTi). These materials are not compatible with other metal
alloys. Do not use any of the VENTURE™ Anterior Cervical Plate System components with the 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.

INDICATIONS

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and
contraindications of spinal instrumentation systems should be well understood by the surgeon. 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 (DDD - 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.

WARNINGS

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of a single use devices may

compromise the structural integrity and the intended function of the device and/or create a risk of contamination of the device,
which could result in patient injury, illness, or death.

CONTRAINDICATIONS

Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation

of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the
WBC differential count.

▪ 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.

▪ Suspected or documented metal allergy or intolerance.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.

▪ Any case requiring the mixing of metals from different components.
▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone

quality, or anatomical definition.

▪ Any case not described in the indications.
▪ Any patient unwilling to cooperate with the post-operative instructions.
▪ Anytime implant utilization would interfere with anatomical structures or expected physiological performance.

POTENTIAL ADVERSE EVENTS

All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events includes:

▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products, and/or graft material including metallosis, staining,

tumor formation, and/or auto-immune disease.

▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, and/or pain.

▪ Bursitis.
▪ Tissue damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears.
▪ 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.

▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ 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.

▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Non-union (or pseudarthrosis), delayed union, and/or mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Atelectasis, ileus, gastritis, herniated nucleus pulposus, and/or retropulsed graft.
▪ Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound

dehiscence, or damage to blood vessels.

▪ Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium.
▪ Development of respiratory problems (e.g. pulmonary embolism, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Death.

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 many
extenuating circumstances may compromise the results. The VENTURE™ Anterior Cervical Plate System is only a temporary
implant 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 VENTURE™ 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 VENTURE™ Anterior Cervical Plate 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 patients are also not good candidates for spine fusion. Patients with poor muscle and bone quality and/or
nerve paralysis are also not good candidates for spine fusion. The implants are not prostheses.

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.

For US audiences only