Additional narrative: this report is for an unknown hindfoot arthrodesis blade/unknown lot.Part and lot number are unknown; udi number is unknown.Concomitant medical products: exact date of implant is unknown; device was reported implanted sometime in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|