Additional narrative: brand name, common device name, procode, manufacturer name, lot #, pma/510k: this report is for an unknown - constructs: lcp low bend medial distal tibia plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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It was reported that on (b)(6) 2022, surgeon, grafted bone non union of a distal tibia.The patient had existing synthes hardware which included a medial distal tibia plate and screws.No direct complaints were made against the hardware.There was no patient consequence.This report is for one (1) unknown constructs: lcp low bend medial distal tibia plate/screws.This is report 1 of 1 for complaint (b)(4).
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