Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports: 3012447612-2020-00660.
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Information added to d3: email address, d8, h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information.The complaint is unrefuted for one (1) of one (1) vitality closure top (pn 07.02011.001) for the failure of post-op loosening and back-out.Medical records were not provided for review.Device evaluation: product was not returned and x-rays were not provided, so this event could not be confirmed.Potential cause root cause was unable to be determined.This event could possibly be attributed to patient or operational conditions that were not detailed by the complainant.Dhr review and related actions lot numbers are not known, so dhr review could not be performed.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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