Depuy Synthes VIPER PRIME Gebrauchsanweisung Seite 15

to breakage of implants, migration of implants or if pulsatile erosion of the vessels occurs because
of close apposition of the implants.
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.
POSSIBLE ADVERSE EFFECTS
1. Bending or fracture of implant.
2. Loosening of the implant.
3. Metal sensitivity or allergic reaction to a foreign body.
4. Infection, early or late.
5. Nonunion, delayed union.
6. Decrease in bone density due to stress shielding.
7. Pain, discomfort, or abnormal sensations due to the presence of the device.
8. Nerve damage due to surgical trauma or presence of the device. Neurological difficulties
including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia.
9. Bursitis.
10. Paralysis.
11. Dural tears experienced during surgery could result in the need for further surgery for dural
repair, a chronic CSF leak or fistula, and possible meningitis.
12. Death.
13. Vascular damage due to surgical trauma or presence of the device. Vascular damage could result
in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could
erode these vessels and cause catastrophic bleeding in the late postoperative period.
14. Screw back out, possibly leading to implant loosening, and/or reoperation for device removal.
15. Damage to lymphatic vessels and/or lymphatic fluid exudation.
16. Spinal cord impingement or damage.
17. Fracture of bony structures.
18. Degenerative changes or instability in segments adjacent to fused vertebral levels.
MAGNETIC RESONANCE (MR) COMPATIBILITY
The VIPER PRIME fenestrated screws have not been evaluated for safety and compatibility in the
MR environment. They have not been tested for heating, migration or image artifact in the MR
environment. The safety of the VIPER PRIME fenestrated screws in the MR environment is unknown.
Scanning a patient who has this device may result in patient injury.
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