The 2.5 mm diameter locking screws (1405-10xx) and 4 hole curved plates ((b)(4)) are provided to the customer within a sterile kit (sk-12) and marked single use.The udi referenced is for the sterile kit, (sk-12), that the product is distributed within.The devices removed were not returned to the manufacturer for evaluation.There is not sufficient information to perform a detailed dhr review as the part and lot information is unknown.The root cause of the revision is related to the screw not being locked into the plate during the original surgery and the fact that the patient was unable to sufficiently avoid forefoot weight baring.This analysis is based on the information provided by the surgeon performing the original and revision surgery.The company will supplement this mdr as necessary and appropriate.
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