Integra Total Foot System 2, Instructions For Use Manual

Page: 7 / 204

6
EN – ENGLISH
• If metal plates or other metallic devices are to be used together with the TFS2, all such devices should be manufac
tured from a metal that has a similar composition to avert possibility of galvanic corrosion or other metallic
reactions.
• Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased
by the selection of the proper size, shape and design of the implants. The patient’s anatomy and indication will
determine the size of the TFS2 plate to be used. The size and shape of the human bones presents limiting
restrictions on the size and strength of implants.
• Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative
instructions could lead to breakage of the implant requiring revision surgery to remove the device.
• The use of TFS2 provides the surgeon a means of bone fixation and helps generally in the management of fractures
and reconstructive surgeries. The implants are intended as a guide to normal healing and are NOT intended to
replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause
the implant to break due to metal fatigue. All metal surgical implants are subject to repeated stress in use which can
result in metal fatigue.
• Failure to immobilize a delayed union or nonunion of bone will result in excessive and repeated stresses which are
transmitted by the body to any temporary internal fixation device prior to the healing of the fracture. Due to normal
metal fatigue, these stresses can cause eventual bending or breakage of the device. Therefore, it is important that
immobilization of the fracture site is maintained until firm bony union (confirmed by clinical and roentgenographic
examination) is established.