This follow-up report is being submitted to supplement initial report.One t3® implant was returned for inspection with a temporary abutment and attached crown.Visual inspection revealed signs of wear at the threads and collar.The crown and abutment were removed using hand tools.The attached screw shows additional signs of wear and some debris.The internal drive feature of the implant contains a significant amount of debris.The abutment tines are noted to be worn and contain additional debris.The reported malfunction cannot be confirmed.No issues were identified during investigation that could have caused or contributed to the reported malfunction.The reported event, "the temporary abutment could not be removed to place the final restoration and that the screw drive feature was damaged, leading to implant removal" could not be recreated.All components were able to be removed with hand tools, and no signs of damage were noted.A device history record review for the reported lot was completed.No unauthorized deviations or non-conformances were noted.The lot was inspected and accepted by quality assurance.Based on inspection of relevant dhr information, the reported devices likely left the zimmer biomet manufacturing site conforming and within specifications.A complaint history review was completed for the reported item and lot.No other complaints were found for the reported condition and lot combination.A definitive root cause of the reported event could not be determined.The most likely probable causes include customer error in driver usage, improper torqueing, and debris caught in the drive feature.
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