DynaClip® Bone Fixation System- Instructions for Use | MedShape DynaClip® Bone Fixation System- Instructions for | Página 4

an effect on the life of the implant. The surgeon must be thoroughly
knowledgeable not only in the medical and surgical aspects of the implant
but also aware of the mechanical and metallurgical aspects of the surgical
implants.
1. Correct selection of the implant is extremely important. The
potential for success in fracture fixation and arthrodesis is increased by
the selection of the proper type of implant. While proper selection can
minimize risks, the size and shape of human bones present limitations
on the size and strenght of implants. Internal fixation devices cannot
withstand the activity levels and/or loads equal to those placed on
normal healthy bone. These devices are not designed to withstand the
unsupported stress of full weight bearing, or load bearing.
2. The devices can break when subjected to increased loading
associated with nonunion or delayed union. Internal fixation devices
are load sharing devices that hold a fracture in alignment until healing
occurs. If healing is delayed, or does not occur, the implant can be
expected to break, deform or fail. Loads produced by weight bearing,
and activity levels may dictate the longevity of the implant.
3. Implant materials are subjected to corrosion. Implanting metals and
alloys subjects them to constant changing environments of salts,
acids, and alkalis that can cause corrosion. Putting dissimilar metals
and alloys in contact with each other can accelerate the corrosion
process that may enhance failure of implants. Every effort should
be made to use compatible metals and alloys when marrying them to
common goal, i.e. screws and plates.
4. The DynaClip Bone Fixation System implants contain Nickel.
Literature supports that a small percentage of the patient population
may have a biological sensitivity to Nickel. Nickel sensitization test is
recommended for all patients before using nickel containing implants.
5. These implants may be surgically removed after healing. Implants
can loosen, fracture, corrode, migrate, or cause pain. If an implant
remains implanted after complete healing, the implant may cause
stress shielding which may increase the risk of re-fracture with an
active patient. The surgeon should weigh the risks versus benefits
when deciding whether to remove the implant. Adequate postoperative
management to avoid re-fracture should follow implant removal.
6. Adequately instruct the patient. Postoperative care is important. The
patient’s ability and willingness to follow instructions is one of the most
important aspects of successful fracture repair and arthrodesis.