It was reported that after an initial bunion surgery, an extruded screw was removed in-office as it was protruding through the skin.Per the surgeon, the screw was in the intercuneiform joint space indicating the dorsal plate was initially placed incorrectly and suspects the patient was non-compliant after his initial bunion surgery.There was no other report of patient impact or injury as a result of this event.No devices were returned to the manufacturer for evaluation.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for screws were reviewed and no nonconformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, based on feedback from the surgeon, the most likely cause is incorrect placement of the dorsal plate and patient non-compliance/post-op activity.The surgical technique and instructions for use include statements regarding plate placement and post-operative care.The company will supplement the mdr as necessary and appropriate.
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