Johnson & Johnson DePuy Synthes ISOLA Spine System Manual page 3

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CAUTION: USA law restricts this device to sale by or on the
order of physician.
IMPORTANT NOTE TO
OPERATING SURGEON
ISOLA, VSP, MOSS MIAMI, EXPEDIUM, VIPER, TIMX and
MONARCH 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
postopera tively 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
DePuy Spine implants are NOT compatible with implants from
other manufacturers unless otherwise specified.
Implants from each of the DePuy Spine systems are NOT
interchangeable with implants from other DePuy Spine
systems unless otherwise specified.
Implants designed to interface with a specific rod diameter are
NOT compatible with other rod diameters unless otherwise
specified. Implants designed to interface with a specific rod
diameter are compatible with rods from other systems having
the same diameter and same material per the table below.
Dual diameter rod components can have a combination of
rod diameters corresponding to the existing straight rod
diameters from each of the Spine Systems listed in the table
below. These dual diameter rods can be used to connect rod
constructs formed from the Original System to rod constructs
from the Secondary System per the table below.
ORIGINAL SYSTEM
EXPEDIUM/
Connects To
VIPER
EXPEDIUM
Connects To
Titanium
EXPEDIUM 5.5
Connects To
Titanium
ISOLA/TIMX Connects To
MONARCH Connects To
MOSS MIAMI Connects To
Dual diameter rods used to connect EXPEDIUM to the
Synthes SYNAPSE System are limited to the 3.5 mm/5.5 mm
and 4.0 mm/5.5 mm titanium tapered rods from the
SYNAPSE System.
Implants made of different materials are NOT compatible unless
otherwise specified. The table below specifies implant material
compatibility.
MATERIAL
Stainless Steel alloys
Titanium alloys
PEEK
Cobalt-Chromium-
Molybdenum
Cobalt-Nickel-
Chromium-Molybdenum
Commercially Pure
Titanium
DePuy Spine prepares Surgical Technique Manuals showing
the use of the implants and instruments for each Spine
System. Contact your DePuy Spine sales representative to
obtain copies of these Surgical Technique Manuals.
ISOLA SPINE SYSTEM
The Posterior ISOLA Spine System is a rod-based system
consisting of spinal rods, eye-rods, plate-rod combinations
(PRC), dual rod connectors, tandem connectors, ISOLA
3 of 164
SECONDARY SYSTEM(S)
EXPEDIUM/VIPER,
ISOLA/TIMX, MONARCH,
MOSS MIAMI
MOUNTAINEER
Synthes SYNAPSE
ISOLA/TIMX,
EXPEDIUM/VIPER,
MONARCH
MONARCH,
EXPEDIUM/VIPER,
ISOLA/TIMX
MOSS MIAMI,
EXPEDIUM/VIPER,
ISOLA/TIMX
COMPATIBLE WITH
Stainless Steel alloys
Titanium alloys, Cobalt-Chromium-
Molybdenum, Cobalt-Nickel-
Chromium-Molybdenum, PEEK,
Commercially Pure Titanium
Titanium alloys
Titanium alloys, Cobalt-Nickel-
Chromium-Molybdenum
Titanium alloys,
Cobalt-Chromium-Molybdenum
Titanium alloys