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Les langues disponibles
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Instructions for use
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Device damage or breakage can occur when the implant is subjected to increased loading associated
with trauma, delayed union, nonunion or incomplete healing. Device breakage could lead to additional
surgery and device removal.
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The patient must be cautioned, preferably in writing, about the use, limitations, and possible adverse
effects of this implant. These cautions include the possibility of the device or treatment failing as a
result of loose fixation and/or loosening, stress, excessive activity, or continuous load bearing past the
average healing time (6-8 weeks), particularly if the implant experiences increased loads due to
delayed union, nonunion, or incomplete bone healing.
The patient must be warned that failure to follow postoperative care instructions can cause the implant
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and/or treatment to fail.
As with any surgical implantation there is a possibility of nerve, bone or soft tissue damage related to
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either surgical trauma or the presence of the implant.
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The implant system has not been evaluated for use in pectus deformity repair, or costochondral junction
fracture.
PRECAUTIONS
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An implant shall never be reused. Previous stresses may have created imperfections which can lead
to a device failure.
Extreme or repeated bending of the implants can cause stresses that may lead to premature device
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failure.
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Ensure that RibLoc® plates and U-clips are not damaged prior to installation and use care when
handling to prevent U-clip deformation.
Over-compression of the U-Clip during implant installation can damage the bone.
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Use of W&H instrument with inappropriate settings could damage the device or harm the patient.
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Instruments should be inspected for wear or damage prior to usage.
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The drill bit shall be discarded after each surgery since after normal use the drill bit can become too
dull to perform as intended.
If a plate cutter is used on the implant take necessary precautions, a sharp edge may have been
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created.
During use of a drill, cutting or installing plates and inserting screws, take necessary precautions when
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in close proximity to sharp edges and points, and be aware that metal debris/fragments can be
generated. Remove any observed debris/fragments from the surgical field with suction or manually,
and dispose of appropriately.
Protect implants against scratching and nicking prior to and during use. Prevent hexalobe drivers, drill
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bits and instruments to come into inadvertent contact with plates as such stress concentrations can
lead to device failure.
The benefits from implant surgery may not meet the patient's expectations or may deteriorate with time
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necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision
surgeries with implants are not uncommon.
ADVERSE EFFECTS
Possible adverse effects include pain, discomfort, or abnormal sensations due to the presence of an
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implant.
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Implant fracture, migration and/or loosening may occur due to excessive activity, prolonged loading
upon the device, incomplete healing, or excessive force exerted on the implant during insertion. These
types of adverse effects could lead to additional surgery and device removal.
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Nerve or soft tissue damage, necrosis of bone or bone resorption, necrosis of the tissue or inadequate
healing may result from the presence of an implant or due to surgical trauma.
U.S. English – US / PAGE 3
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