Johnson & Johnson DePuy Spine EXPEDIUM SFX, Manual

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en
CAUTION: USA law restricts this device to sale by or on
the order of physician.
IMPORTANT NOTE TO OPERATING
SURGEON
EXPEDIUM
®
SFX
®
Cross Connector System spinal
implants, 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 activi­
ties 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 never­
theless 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.
Because of the limitations imposed by anatomic consider­
ations and modern surgical materials, metallic implants
cannot be made to last indefinitely. Their purpose is to
provide temporary internal support while the fusion mass
is consolidating. 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.
The surgeon may remove these implants after bone fusion
occurs. 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.
DESCRIPTION
EXPEDIUM SFX Cross Connector System
The EXPEDIUM SFX Cross Connector System is designed
to transversely connect two rods used in posterior spinal
instrumentation constructs. The SFX Cross Connector
System consists of fixed and adjustable transverse
connectors available in titanium alloy conforming to ASTM
F­136 specifications and stainless steel conforming to
ASTM F­138 specifications.
The titanium alloy EXPEDIUM SFX Cross Connector
System is for use with either the 5.5mm or 6.35mm
diameter rods from the following spine systems; ISOLA ® ,
VSP
®
, MOSS
®
MIAMI, EXPEDIUM
®
, VIPER
®
, TIMX
®
and
MONARCH
®
. The stainless steel EXPEDIUM SFX Cross
Connector System is for use with either the 5.5mm or
6.35mm diameter rods from the following spine systems;
ISOLA
®
, VSP
®
, MOSS
®
MIAMI and EXPEDIUM
®
.
The EXPEDIUM SFX Cross Connector System is NOT
for use with ISOLA 4.75mm diameter rods, MOSS MIAMI
4.0mm diameter rods or MOSS MIAMI 5.0mm diameter rods.
Indications
The EXPEDIUM SFX Cross Connector System is designed
to transversely connect two rods used in posterior spinal
instrumentation constructs. The EXPEDIUM SFX Cross
Connector System devices are intended for use with
components of the commercially available EXPEDIUM,
VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and
TIMX Spine Systems.
Please refer to DePuy Spine product insert 0902­90­015 for
a complete description of each spine system’s indications.
CLEANING AND STERILIZATION
Implants and instruments of the EXPEDIUM SFX Cross
Connector System may be provided either sterile or
non­sterile and this will be clearly identified on the
product labels.
Sterile Implants
For the implants supplied sterile, the contents are sterile
unless the package is damaged, opened, or the expiration
date on the device label has passed. The integrity of the
packaging should be checked to ensure that the sterility of
the contents is not compromised. Remove implants from
packaging, using aseptic technique, only after the correct
size has been determined.
PRECAUTION: Do not use implants if the condition of
the package and/or labeling indicates a chance that the
devices may not be sterile.
Implants supplied sterilized from the manufacturer must
not be re­sterilized.
Non-sterile Implants
For the implants supplied non­sterile, they will be supplied
clean. ISO 8828 or AORN recommended practices for in­
hospital sterilization should be followed for all components.
Cleaning instructions
Inspect visually for damage or the presence of blood or
tissue. If blood or tissue is observed on the implant, it must
be thoroughly cleaned manually using a soft brush and
neutral pH detergent or discarded.