Cleaning And Sterilization - Depuy Synthes EXPEDIUM SFX Handbuch

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 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.
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 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 F-136 specifications and
stainless steel conforming to ASTM F-138 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
MIAMI, EXPEDIUM , VIPER
®
, VSP , MOSS
® ®
, TIMX and MONARCH
® ® ®
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
EXPEDIUM , and VIPER
®
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.
Implants made of different materials are NOT compatible
unless otherwise specified. The table below specifies implant
material compatibility.
Material
Stainless Steel
alloys
Titanium alloys
Cobalt-Chromium-
Molybdenum
Cobalt-Nickel-Chro-
mium-Molybdenum
Commercially Pure
Titanium
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 0902-90-105 (US)
or 0902-90-015 (worldwide outside of US) 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 non-
sterile 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
the contents is not compromised. Remove implants from
3 of 176
, VSP , MOSS
® ®
.
®
Compatible with
Stainless Steel alloys, Titanium
alloys, Commercially Pure Titanium
Titanium alloys, Commercially Pure
Titanium, Cobalt-Chromium-Molybde-
num, Cobalt-Nickel-Chromium-Molyb-
denum, Stainless Steel Alloys
Titanium alloys, Commercially Pure
Titanium, Cobalt-Nickel-Chromium-
Molybdenum
Titanium alloys, Commercially
Pure Titanium, Cobalt-Chromium-
Molybdenum
Titanium alloys, Commercially Pure
Titanium, Stainless Steel Alloys
MIAMI,
®