Depuy Synthes VIPER PRIME Gebrauchsanweisung Seite 5

WARNINGS
1. Refer to the STAND ALONE USE section of this package insert for a list of warnings, precautions
and adverse events associated with the use of the fenestrated screws.
2. Refer to the fenestrated screw cannula package insert for warnings associated with the use of the
fenestrated screw cannula.
3. Refer either to the package inserts of the CONFIDENCE High Viscosity Spinal Cement,
CONFIDENCE Spinal Cement System kits, 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.
4. The 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.
5. Pay special attention to the delivery system instructions from the corresponding package insert.
Aggressive cement injection may result in cement leakage or extravasation.
6. 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.
7. 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.
8. 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.
9. Do not continue injection beyond the working time of the cement. After cement introduction is
complete, the 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.
10. 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.
11. 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.
12. Following cement introduction, positioning of the patient should be maintained securely
throughout the setting phase as described in package inserts for either the CONFIDENCE High
Viscosity Spinal Cement, CONFIDENCE Spinal Cement System kits, or the VERTECEM V+
Cement Kit.
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