Integra Total Foot System 2 Instructions For Use Manual page 9

EN – ENGLISH
STERILITY
The Integra TFS2 system components are provided non-sterile, and must be cleaned and sterilized prior to use. Do
not re-use implants, as they are single use only. Detailed reprocessing instructionsare provided in LC-04-0000-0013.
ADVERSE EVENTS
• Loosening, bending, cracking or fracture of the screw or loss of fixation in bone attributable to nonunion.
• Loss of anatomic position with nonunion or malunion with rotation or angulation.
• Infection, both deep and superficial.
• Allergies and other reaction to the device material.
SURGICAL PROCEDURE
A Surgical Technique brochure is available which outlines the basic procedure for device implantation and the use of
specialized surgical instrumentation. It is the responsibility of the surgeon to be familiar with the procedure before
use of these products. Each surgeon must evaluate the appropriateness of the surgical technique used based on per-
sonal medical training and experience. Copies of the surgical technique may be obtained online at www.integralife.
com, by contacting customer service at 1-800-654-2873, or by contacting your local sales representative.
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