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10. Nerve damage due to surgical trauma or presence of the
device. Neurological difficulties including bowel and/or
bladder dysfunction, impotence, retrograde ejaculation, and
paraesthesia.
11. Bursitis.
12. Paralysis.
13. 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.
14. 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. Also local vascular
erosion and occlusion may result due to cement use.
15. Damage to lymphatic vessels and/or lymphatic fluid
exudation.
16. Spinal cord impingement or damage.
17. Fracture of bony structures. Fracture, degenerative changes
or instability in segments adjacent to fused vertebral levels.
18. Anaphylaxis. Allergic pyrexia.
19. Transitory fall in blood pressure.
20. Hypertension or hypotension.
21. Thrombophlebitis.
22. Hemorrhage and hematoma.
23. Cardiac arrythmia.
24. Heterotopic bone formation.
25. Hypoxemia.
26. Bronchospasm.
27. Pain and/or loss of function. Transitory worsening of pain due
to heat released during cement polymerization.
28. Hematuria or Dysuria.
29. Bladder fistula.
30. Local neuropathy.
31. Nerve entrapment and dysphagia due to extrusion of the bone
cement beyond its intended application.
32. Intestinal obstruction because of adhesions and stricture of
the ileum due to heat released during polymerization.
33. Sudden death.
34. Adverse tissue reaction.
35. Pneumonia.
36. Pulmonary infection.
37. Intercostal neuralgia, neuritis, nerve root pain, radiculopathy.
38. Pneumothorax.
39. Collapse of a vertebra adjacent to a treated level, due to
osteoporotic disease.
40. Cement extravasation into soft tissue.
41. Cement leakage into intervertebral disc(s).
42. Skin burns from fluoroscopy exposure.
43. Hypersensitivity in susceptible persons, which may result in
an anaphylactic response.
44. Adverse cardiovascular reaction.
Please refer to the package inserts for the CONFIDENCE SPINAL
CEMENT SYSTEM, the CONFIDENCE Spinal Cement, the
V-MAX Mixing and Delivery Device, the VERTEBROPLASTIC
Radiopaque Resinous Material, and the VERTECEM V+ Cement
Kit for adverse events associated with the cement use.
WARNINGS
1. Refer to the VIPER/VIPER2 System and VIPER Fenestrated
Screw Cannulas package insert for warnings associated with
the use of the VIPER/VIPER2 System and VIPER Fenestrated
Screw Cannulas.
2. Depending on the cement used, refer to the package inserts
of the CONFIDENCE SPINAL CEMENT SYSTEM Kit and
the CONFIDENCE Spinal Cement, the V-MAX Mixing and
Delivery Device and the VERTEBROPLASTIC Radiopaque
Resinous Material, or the VERTECEM V+ Cement Kit for a list
of warnings associated with the cement use.
Follow the time
temperature chart for mixing, delivery, and setting time of
the cement used very carefully.
3. The VIPER Fenestrated Screws should NOT be placed
bicortically. It is very important not to breach the pedicle wall
or the anterior cortex of the vertebral body to avoid cement
extrusion into the retroperitoneal space. This may result
in serious complications, including cement extravasation,
embolism or even death, especially if the cement is
inadvertently delivered through the tip of the screw.
4. Pay special attention to the delivery system instructions
from the corresponding package insert. Aggressive cement
injection may result in cement leakage or extravasation.
5. Accurate pedicle preparation, screw sizing and placement
must be practiced, as well as a careful cement delivery
technique. There may be an increased risk of cement egress
into pedicle if the screw length is too short for the vertebral
2018-09-06 05:45:44
Summary of Contents for DePuy Synthes VIPER System
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