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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 VERTEBROPLASTIC
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 needed,
use a second CONFIDENCE SPINAL CEMENT SYSTEM
11cc Kit or V-MAX Mixing and Delivery Device.
15. Do not re-sterilize any components packaged sterile. They are
for single patient use only. These components are sterile only
if the package is unopened and undamaged. DePuy Spine will
not be responsible for any product that is re-sterilized.
16. Extreme caution should be exercised when there is disruption
to the posterior cortex of the vertebral body or the pedicle as
this increases the risk of cement extravasation into the neural
foramen or spinal canal.
17. Cement leakage can also occur when injecting CONFIDENCE
11cc High Viscosity Spinal Cement, VERTEBROPLASTIC
Radiopaque Resinous Material, or the VERTECEM V+ Cement
Kit if cement enters a blood vessel or if unseen microfractures
are prevalent.
18. If the CONFIDENCE 11cc High Viscosity Spinal Cement is
seen outside of the vertebral body or in the circulatory system
during the procedure, immediately stop injecting the cement.
If using the CONFIDENCE Spinal Cement Delivery System,
turn the pump handle counter-clockwise to stop the injection
of the cement.
19. You may wish to consider the additional precaution of using
Computerized Tomography (CT) guidance for high-risk cases.
20. Assure that all system components are firmly connected prior
to cement introduction. Improperly secured connections could
result in the unintended disconnection of components.
21. Always cancel the pressure within the system when cement
introduction is no longer desired per the CONFIDENCE
SPINAL CEMENT SYSTEM 11cc Kit package insert.
22. Do not attempt to force the injection of material if excessive
resistance is felt. Always determine the cause of the
resistance and take appropriate action.
23. Inadequate fixation or unanticipated post-operative events may
affect device performance causing failure in any of several
modes. These modes may include bone-metal, bone-cement
and cement-metal interface, implant fracture or bone failure.
24. Cement leakage may cause tissue damage, nerve or circulatory
problems, and other serious adverse events. These risks may
increase with the number of spinal levels where cement is
utilized, and also with the volume of cement used.
PRECAUTIONS
1. The implantation of pedicle screw spinal systems should be
performed only by experienced spinal surgeons with specific
training in the use of this pedicle screw spinal system because
this is a technically demanding procedure presenting a risk of
serious injury to the patient. The surgeon must be thoroughly
knowledgeable not only in the medical and surgical aspects
of the implant, but must also be aware of the mechanical
and metallurgical limitations of metallic surgical implants.
2018-09-06 05:45:44
Summary of Contents for DePuy Synthes VIPER System
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