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: 3012447612-2020-00598 to 3012447612-2020-00603.
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This follow-up report is being submitted to relay additional information.Additional in: h6: component,investigation type, findings, and conclusions.The complaint is unrefuted for three vitality monoaxial screws for the failure of inadequate locking resulting in post-operative loosening, allowing the closure tops to migrate.This device is used for treatment.No medical records were provided with the complaint.Inspection.The products were not returned, but a photo of an x-ray was provided.When reviewing the x-ray, it was unclear which set screws loosened/migrated.The complaint remains unrefuted.Dhr review.The lot numbers were not provided, so the dhrs could not be reviewed.Potential root cause.A definitive root cause cannot be determined with the information provided.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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