Loading...
Loading...
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.