One impl tapered scr-v sbm 3.7mm 3.5mm 10mm (tsvb10) was returned and one unknown driver was not returned for investigation.Visual evaluation of the as returned implant identified no damage to the implant.Functional testing was performed with an in-house driver and the implant and mount engaged and retained on the driver.Pre-existing conditions noted on the per were low bone density ¿ type iii.The reported device had been placed on tooth #4 (universal).X-ray & picture evaluation: picture or x-ray evidence not provided.Appropriate documentation was reviewed.Dhr review for the lot (1251442) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1251442) for similar events and no other complaint was identified.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur (implant) and could not be verified (driver) and the reported event was non-verifiable.The following sections have been updated: g6: checked "follow-up." h3: changed "yes" to "no.".
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