A heal collar 4.5x4.5, 5mm (hc445) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and damage at threads and does not seat.Functional testing was performed for the returned product with an in-house stock device and did not seat as intended pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (2019060118).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019060118) for similar event and no other complaint was identified.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation is the clinician does not follow the recommended protocol for product placement and final seating no further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.The following sections have been updated: g7: checked "follow-up.".
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