Integra Total Foot System 2 Instructions For Use Manual page 8

EN – ENGLISH
• No partial weight bearing or non-weight bearing device can be expected to withstand the unsupported stresses
of full weight bearing. Until firm bone union is achieved, the patient should employ adequate external support and
restrict physical activities which would place stress upon the implant or allow movement at the fracture site and
delay healing.
• Detailed written instructions on the use and limitations of the device should be given to the patient. If partial
weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending
or breakage of the device are complications which may occur as a result of the weight bearing or muscle activity.
An active patient or a debilitated or demented patient who cannot properly utilize weight support devices may be
particularly at risk during postoperative rehabilitation.
• While the surgeon must make the final decision on implant removal, whenever possible and practical for the
individual patient, fixation devices should be removed once their service as an aid to healing is accomplished,
particularly in younger more active patients.
• The MR environment presents risks to patients with metal implants. Review of the available literature documents
that metal implants may heat resulting in tissue damage and may migrate out of position. They may also cause
artifact affecting image quality. Physicians should take these risks into consideration when recommending MRI
imaging for patients with metal implants. Note: Integra TFS2 has not been evaluated for safety and compatibility in
the MR environment. The Integra TFS2 has not been tested for heating or migration in the MR environment.
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