It was reported that during the procedure the threads of ten closure tops were damaged.The initially-implanted closure tops, that were being removed during this procedure, were used to complete the case.There were no reported patient impacts or surgical delays.This is report six of ten.
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It was reported that during the procedure the threads of ten closure tops were damaged.The initially-implanted closure tops, that were being removed during this procedure, were used to complete the case.There were no reported patient impacts or surgical delays.This is report six of ten.
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Additional information in b4, d4 (udi), g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.The returned closure top was evaluated.Visual inspection revealed that the threads were damaged.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.One non conformance was identified for a missing piece and documentation error: therefore, not related to the reported failure.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The likely cause for damaged threads is due to cross-threading.The cross threading can often occur due to misalignment of the screw head on the extender sleeve.
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