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EXPEDIUM
®
Fenestrated Screw System
Instructions for Use
IMPORTANT INFORMATION
Please Read Before Use
INDICATIONS FOR USE
The EXPEDIUM
®
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 EXPEDIUM Fenestrated Screw System is contraindi-
cated 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 EXPEDIUM Fenestrated Screw System consists of Fenestrated
Screws and Clip-on Delivery System (includes a Cement Cannula
and a Clip). The EXPEDIUM Fenestrated Screw is a cannulated
polyaxial screw with fenestrations at the distal end of the screw
that are designed for cement introduction. The EXPEDIUM
Fenestrated Screw is designed for use in open and percutaneous
approaches and comes in a variety of sizes and lengths. It is
compatible for use with EXPEDIUM Spine Systems and VIPER
®
and VIPER
®
2 Spine Systems.
The EXPEDIUM Fenestrated Screw System can be used either
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,
EXPEDIUM 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, 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 Clip-on Delivery System.
2018-03-09 04:03:33