A navigator® certain® implant mounts, 3.4mm(d) x 4(l) (item # (b)(4)) and was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information using the item #/ item # and lot # (dhr/ifu/rmf).No pre-existing conditions were noted on the per.The reported device was located on tooth #(b)(6) and was used for an unknown period of time.Pictures or x-ray images were not provided.Dhr review and complaint history review could not be performed for the reported (b)(4) , as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (item # (b)(4)) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformance/capa/hhe/d/ie/product holds for the reported device related to the reported event.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event (screw fracture) or devices ((b)(4)).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.A definitive cause could not be identified.
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