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The surgeon should also be familiar with the principles and
technique of spinal cement delivery, including possible side
effects and limitations, and with the physiology and pathology
of the selected anatomy.
2. A thorough pre-operative check-up of the patient must be
carried out before the operation.
3. Postoperative care is extremely important. The patient must
be instructed in the limitations of the metallic implant and be
warned regarding weight bearing and body stresses on the
appliance prior to firm bone healing. The patient should be
warned that noncompliance with postoperative instructions
could lead to failure of the implant and possible need thereafter
for additional surgery to remove the device.
4. During the application of the cement, radiological control is
essential so that the operator can follow the progress of the
filling and stop the procedure if the slightest leakage of cement
is detected. Use appropriate imaging techniques such as
fluoroscopy or CT imaging guidance to confirm correct screw
placement, absence of damage to surrounding structures and
appropriate location of injected cement.
5. If surgeon chooses to complete a biopsy prior to screw
placement, care should be taken not to place the tip of the
biopsy needles beyond the desired location of the screw tip in
order to reduce leakage or extravasation risk.
6. VIPER Fenestrated Screws System implants and instruments
must never be reused. An explanted implant should never
be reimplanted. Even though a device appears undamaged
after explanting, it may have small defects and internal stress
patterns that may lead to early breakage.
7. Reuse of single use implants and instruments may compromise
device performance and patient safety and can also cause
cross-contamination leading to patient infection.
8. These procedures should only be performed in medical
settings where emergency surgery is available.
9. The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is
designed for use only with CONFIDENCE 11cc High Viscosity
Spinal Cement. The device may not be compatible with
alternate materials. The V-MAX Mixing and Delivery Device is
designed for use only with VERTEBROPLASTIC Radiopaque
Resinous Material. The device may not be compatible with
alternate materials.
IMPORTANT PHYSICIAN INFORMATION
1. The metallic implants available for implantation, like any other
temporary internal fixation devices, have a finite useful life.
The patient’s activity level has a significant impact on this useful
life. Your patient must be informed that any activity increases
the risk of loosening, bending, or breaking of the implant
components. It is essential to instruct patients about restrictions
to their activities in the postoperative period and to examine
patients postoperatively to evaluate the development of the
fusion mass and the status of the implant components. Even if
solid bone fusion occurs, implant components may nevertheless
bend, break, or loosen. Therefore, the patient must be made
aware that implant components may bend, break, or loosen
even though restrictions in activity are followed.
2. Because of the limitations imposed by anatomic considerations
and modern surgical materials, metallic implants cannot be
made to last indefinitely. Their purpose is to provide temporary
internal support and fixation while fusion mass is consolidating
or fracture is healing, or for the palliative reconstruction of
the tumor patients. These types of implants are more likely to
fail if no bone graft is used, if a pseudarthrosis develops, or if
patients have severe or multiple preoperative curves.
3. The surgeon may remove these implants after bone fusion
occurs. In some cases, removal is indicated because the
implants are not intended to transfer or to support forces
developed during normal activities. The possibility of a second
surgical procedure must be discussed with the patient, and the
risks associated with a second surgical procedure must also
be discussed. If the implants do break, the decision to remove
them must be made by the physician who must consider
the condition of the patient and the risks associated with the
presence of the broken implant.
4. These devices are not intended or expected to be the only
mechanism for support of the spine. Regardless of the etiology
of the spinal pathology, for which implantation of these devices
was chosen, it is the expectation and requirement that a spinal
fusion or arthrodesis be planned and obtained. Without solid
biological support provided by spinal fusion, the devices cannot
be expected to support the spine indefinitely and will fail in any
of several modes. These modes may include bone-metal, bone-
cement and cement-metal interface failure, implant fracture, or
bone failure.
5. The safety and effectiveness of pedicle screw spinal systems
have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with
instrumentation. These conditions are significant mechanical
instability or deformity of the thoracic, lumbar, and sacral spine
secondary to severe spondylolisthesis (grades 3 and 4) of the
L5-S1 vertebra, degenerative spondylolisthesis with objective
evidence of neurologic impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion
2018-09-06 05:45:44
Summary of Contents for DePuy Synthes VIPER System
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