DePuy Mitek MILAGRO BR Manual Del Usuario página 4

CONTRAINDICATIONS
This device is not cleared for screw attachment or
fixation to the posterior elements (pedicles) of the
cervical, thoracic or lumbar spine.
Insufficient quantity or quality of bone, comminuted
bone surfaces, or pathologic bone conditions such as
cystic change or severe osteopenia that would impair
the ability of the MILAGRO BR Interference Screw to
securely fixate to the bone.
Physical conditions which would eliminate, or tend to
eliminate, adequate implant support or retard healing,
i.e., blood supply limitations, infections.
Implant/material sensitivity/foreign body sensitivity.
Conditions which tend to pre-empt the patient's ability
or healing period, such as senility, mental illness or
alcoholism.
WARNINGS
If resistance is felt during the insertion of a MILAGRO
BR Interference Screw over a guidewire, stop and
confirm that the guidewire is not entrapped. If
entrapped, back out the screw and withdraw the
guidewire.
This product is for single-use only. It has not been
designed to be re-used/re-sterilized. Reprocessing
may lead to changes in material characteristics such
as deformation and material degradation which may
compromise device performance. Reprocessing
of single use instruments can also cause cross-
contamination leading to patient infection. These risks
may potentially affect patient safety.
PRECAUTIONS
This anchor is supplied STERILE, and is intended for
single use only. Do not resterilize. Do not use if sterile
packaging appears to be damaged.
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