Medtronic SPS00162 Instructions for Use

0381080_Rev A

BONE GRAFT WASHER

IMPORTANT INFORMATION ON THE BONE GRAFT WASHER

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: [phone] (in U.S.A.)
901-396-3133 (Outside of U.S.A.)

Fax: [phone]

03/2008

ENGLISH

PURPOSE:

The BONE GRAFT WASHER is a temporary implant used to prevent bone graft
extrusion. The washer is also intended to provide temporary stabilization and
augment development of a solid spinal fusion.

DESCRIPTION:

The BONE GRAFT WASHER consists of a variety of sizes of washers used with a

6.5mm screw, as well as instrument sets.

The BONE GRAFT WASHER is made of titanium alloy (Ti-6A1-4V). The washer may
also be made of commercially pure titanium. Stainless steel and titanium implant
components must not be used together in a construct. This system uses a 6.5mm
ZPLATE II™ screw fabricated from titanium alloy. MEDTRONIC expressly warrants
that these devices are fabricated from the material specification on its labeling.

Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded. See the MDT Catalog or price list for further information
about warranties and limitations of liability.

INDICATIONS, CONTRAINDICATIONS AND POSSIBLE ADVERSE
EFFECTS.

INDICATIONS:

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level
(T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior,
anterolateral, or posterior spinal systems made of compatible materials (e.g.,
commercially pure titanium or titanium alloy).

CONTRAINDICATIONS:

Contraindications include, but are not limited to:

1. Infection, local to the operative site.

2. Fever or leukocytosis.

3. Morbid obesity.

4. Pregnancy.

5. Mental illness.

6. Any medical or surgical condition which would preclude potential benefit of spinal
implant surgery, such as the presence of tumors or congenital abnormalities,
elevation of sedimentation rate unexplained by other diseases, elevated white
blood count (WBC), or a marked left shift in the WBC differential count.

7. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis.
Osteoporosis is a relative contraindication since this condition may limit the
degree of obtainable correction and/or the amount of mechanical fixation.

8. Suspected or documented metal allergy or intolerance.

9. Any case needing to mix metals from different components.

10. Any case not needing a bone graft and fusion or requiring fracture healing.

11. Curves originating superior to T-5 may be a relative contraindication since the
exposure may be difficult, the vertebral bodies are small, and the correction is
minimal.

12. Any patient having inadequate tissue coverage over the operative site, or
inadequate bone stock or bone quality such as in the sacrum

13. Any time implant utilization would interfere with anatomical structures or expected
physiological performance.

14. Any patient who will not follow postoperative instructions, such as drug/alcohol
abuse patients, and are unwilling to restrict postoperative activities.

15. Any case not described in the Indications.

16. Any patient unwilling to follow the postoperative instructions.
Contraindications of this device are consistent with those of other anterior spinal

instrumentation systems. This spinal implant system is not designed, intended,
or sold for uses other than those indicated.

POSSIBLE ADVERSE EFFECTS:

1. Early or late loosening of the components.

2. Implant migration.

3. Disassembly, bending, loosening, slippage, and/or breakage of any or all of the
components or instruments.

4. Foreign body reaction to the implants including possible tumor formation,
autoimmune disease, metallosis, and/or scarring.

5. Pressure on the skin possibly resulting in skin breakdown from component parts

where there is inadequate tissue coverage over the implant. Implant or graft
extru¬sion through the skin. Wound complications.

6. Loss of proper spinal curvature, correction, height, and/or reduction.

7. Infection.

8. Bone fracture or stress shielding at, above, or below the level of surgery.

9. Non-union (or pseudoarthrosis).

10. Loss of neurological function, appearance of radiculopathy, dural tears, and/or
development of pain. Neurovascular compromise including paralysis or other
types of serious injury. Cerebral spine fluid leakage.

11. Gastrointestinal, urological, and/or reproductive system compromise, including
sterility, impotency, and/or loss of consortium.

12. Hemorrhage of blood vessels and/or hematomas.

13. Cessation of growth of the fused portion of the spine.

14. Discitis, arachnoiditis, and/or other types of inflammation.

15. Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.

16. Bone graft donor site pain.

17. Inability to resume activities of normal daily living.

18. Death.

NOTE: Additional surgery may be necessary to correct some of these anticipated
adverse reactions.

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. BONE GRAFT WASHER components are temporary
implants used to stabilize the bone graft. This system is intended to be used to
augment the development of a spinal fusion by providing temporary stabilization.
This system is not intended to be the sole means of spinal support. Use of this
product without a bone graft or in cases that develop into a non-union will 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 reduction, and proper selection and placement of the implant are important
considerations in the successful utilization of the BONE GRAFT WASHER 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 abuse patients are also
poor candidates for spine fusion. Patients with poor muscle and bone quality and/
or nerve paralysis are also poor candidates for spine fusion. The use of allograft
material may not give as good a result as pure autograft.