Johnson & Johnson DePuy Synthes VIPER System, Instructions For Use Manual

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0086
0902-90-102 Rev. C
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VIPER
®
Fenestrated Screw System
Instructions for Use
IMPORTANT INFORMATION
Please Read Before Use
INDICATIONS FOR USE
The VIPER
®
Fenestrated Screw System is intended to be used with
the CONFIDENCE SPINAL CEMENT SYSTEM
®
or the V-MAX
®
Mixing and Delivery System and the VERTEBROPLASTIC
®
Radiopaque Resinous Material or the VERTECEM V+ Cement Kit
to provide immobilization and stabilization of spinal segments in
the treatment of acute and chronic instabilities or deformities of
the thoracic, lumbar and sacral spine in patients with diminished
bone quality (e.g., osteoporosis, osteopenia, metastatic disease).
It is intended 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.
CONTRAINDICATIONS
The use of VIPER Fenestrated Screw System is contraindicated in
patients presenting with any of the following conditions:
•
Disease conditions that have been shown to be safely and
predictably managed without the use of internal fixation devices.
•
Acute compromise of the vertebral body or walls of the pedicles
and disruption of the posterior cortex.
•
Anatomical damage of the vertebra that prevents safe screw
implantation.
•
Active or incompletely treated infection.
•
Coagulation disorders, or severe cardiopulmonary disease.
•
Haemorrhagic diasthesis.
• Spinal stenosis > 20% caused by retropulsed fragments.
•
Vertebral body collapse to less than 1/3 (33%) original height.
•
Coagulopathy or inability to reverse anti-coagulant therapy
(both during and approximately 24 hours post-procedure).
•
Allergic reaction to any of the components of the cement or
metal used.
•
Relative contraindications include obesity, certain degenerative
diseases, and foreign body sensitivity. In addition, the patient’s
occupation or activity level or mental capacity may be relative
contraindications to this surgery. Specifically, patients who
because of their occupation or lifestyle, or because of conditions
such as mental illness, alcoholism, or drug abuse, may place
undue stresses on the implant during bony healing and may be
at higher risk for implant failure.
DESCRIPTION
The VIPER Fenestrated Screw System consists of Fenestrated
Screws and Delivery System (includes a Cement Cannula
and Alignment Guides). The VIPER Fenestrated Screw is a
cannulated polyaxial screw with fenestrations at the distal end of
the screw that are designed for cement introduction. The VIPER
Fenestrated Screw is designed for use in open and percutaneous
approaches and comes in a variety of sizes and lengths. Refer
to the EXPEDIUM
®
Spine System, VIPER
®
System, and
VIPER
®
2 System package insert for compatibility with other
DePuy Spine systems.
The VIPER Fenestrated Screw System can be used with the
CONFIDENCE SPINAL CEMENT SYSTEM, or the V-MAX Mixing
and Delivery Device and the VERTEBROPLASTIC Radiopaque
Resinous Material, or the VERTECEM V+ Cement Kit. When
used with the CONFIDENCE SPINAL CEMENT SYSTEM, VIPER
Fenestrated Screw Cement Cannula must be attached to the
CONFIDENCE Spinal Cement Delivery System. When used with the
V-MAX Mixing and Delivery Device with the VERTEBROPLASTIC
Radiopaque Resinous Material or the VERTECEM V+ Cement Kit,
a CONFIDENCE Needle Adapter (sold separately as an accessory
to CONFIDENCE Spinal Cement System) must be used to attach
the V-MAX Flexible Tubing luer lock to the Cement Cannula.
2018-09-06 05:45:44