Depuy Synthes VIPER Gebrauchsanweisung Seite 9

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. Cerebrovascular accident.
35. Adverse tissue reaction.
36. Pneumonia.
37. Pulmonary infection.
38. Intercostal neuralgia, neuritis, nerve root pain,
radiculopathy.
39. Pneumothorax.
40. Collapse of a vertebra adjacent to a treated level, due to
osteoporotic disease.
41. Cement extravasation into soft tissue.
42. Cement leakage into intervertebral disc(s).
43. Skin burns from fluoroscopy exposure.
44. Hypersensitivity in susceptible persons, which may result
in an anaphylactic response.
45. 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 body, or if excessive cement volume is pumped
into the vertebral body.
6. When using cement to augment multiple screws or levels,
attention must be paid not to exceed the working time of
the cement prior to completion of cement delivery through
the screw. When the cement working time is close to
completion, a new cement package should be opened to
mix and deliver cement through the next screw/level.
7. It is critical that NO torsion movement should be applied
to the screw after injecting the cement in order to avoid
breaking the cement bridges between screw and bone.
8. Do not continue injection beyond the working time of the
cement. After cement introduction is complete, the VIPER
Fenestrated Screw Cement Cannula must be removed
immediately. The cement setting while the cannula is still
connected to the screw may lead to difficulty in removal,
and a new cannula may be required for additional levels.
9. Strict adherence to good surgical principles and
techniques is essential. Deep wound infection is a serious
post-operative complication and may require total removal
of the embedded cement. Deep wound infection may be
latent and may not manifest itself even for several years
post-operatively.
10. Hypotensive reactions may occur with any procedure that
involves cement use and some may progress to cardiac
arrest. For this reason, patients should be monitored for
any change in blood pressure during and immediately
following the application of the cement.
11. Following cement introduction, positioning of the
patient should be maintained securely throughout the
setting phase as described in package inserts for either
the CONFIDENCE SPINAL CEMENT SYSTEM, the
Veterbroplastic Radiopaque Resinous Material, or the
VERTECEM V+ Cement Kit depending on which cement
was used.
12. The long-term safety and efficacy of the VIPER
Fenestrated Screw System with cement augmentation
have not yet been established.
13. The safety and efficacy of the VIPER Fenestrated Screw
System in pregnant women or in children has not yet
been established.
14. The mixing/delivery device is designed for single use with
one package of spinal cement. If additional material is
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