Contraindications - Johnson & Johnson DePuy Synthes Latarjet EXPERIENCE Instability Shoulder Mode D'emploi

INDICATIONS
The Latarjet EXPERIENCE Cortical Screw Set is intended to
provide the orthopedic surgeon with a means of bone fixation
and to assist in the management of reconstructive surgeries.

CONTRAINDICATIONS

• Cases when there is an active infection.
• Conditions which tend to retard healing, such as blood
supply limitations, previous infections, etc.
• Insufficient quantity or quality of bone.
• Conditions that restrict the patient's ability or willingness to
follow post-operative instructions during the healing process.
• Foreign body sensitivity–where material sensitivity is
suspected, appropriate tests should be made and sensitivity
ruled out prior to implantation.
• These devices are not approved for screw attachment or
fixation to the posterior elements (pedicles) of the cervical,
thoracic, or lumbar spine.
WARNINGS
• Federal Law (United States of America) restricts this Device
to sale by, or on the order of a physician.
• The Screws may be used with or without the Top Hats – the
decision is at the discretion of the physician.
• The Devices should be inspected prior to use to ensure
absence of damage.
• The Devices are supplied STERILE and do not require
pre-use processing.
• The Devices are intended for single-patient use only, reusing
or reprocessing the implant may result in bio-contamination,
degraded performance, or loss of functionality.
• Inspect the packaging before use. If tampering/damage
exists or the packaging has been opened or package label is
missing, do not use the Devices.
• It is imperative that the surgeon and operating room staff be
fully conversant with the appropriate surgical technique prior
to using these Devices.
• Until firm bone union is achieved, the patient should restrict
physical activities which would place stress upon the Devices.
Detailed written instructions on such limitations should
be given to the patient. The patient must be warned that
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