Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that, the spinal fixation or spondy l4-5 6 months after surgery the treating physician noticed that one screw was broken, and rotated and the screw on the contralateral side has a tilted screwhead.This was not present during primary implantation and has occurred in the months after the surgery.The surgery itself was successful and no postoperative events have occurred that might explain the screw breakage.The patient was treated for a spondy grade 1 at level l4-5.Primary surgery date (b)(6) 2018 patient gender male.Weight (b)(6).No other patient data is available.
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