Zimvie did not receive one (1) unknown encode emergence ha for evaluation.Visual inspection could not be performed.The investigation has been performed based on all available information, complaint history review (chr), and the risk management file (rmf).Dhr review by lot number could not be performed, as the item/lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the unknown encode emergence ha dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: ¿dental : fit : does not seat¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was the improper placing of screw or the abutments internal connection (abutment-implant interface) anti-rotational feature is designed too wide or the clinician selects incorrect abutment size.Please note, a definitive root cause could not be determined because the device was not returned.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported coob was non-verifiable, since the condition of the product/packaging when received by the customer are unknown / non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
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