NA 241.624Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167415), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A SEVERELY COMMINUTED RIGHT OPEN FRACTURE WITH A LOCKING CALCANEAL PLATE ON AN UNKNOWN DATE. NINE SCREWS WERE USED FOR FIXATION. THE PATIENT EXPERIENCED A DEEP INFECTION FOR WEEKS POSTOPERATIVELY, AND A BELOW THE KNEE AMPUTATION WAS PERFORMED. THE PATIENT DID NOT RETURN TO WORK DUE TO DISABILITY.

  Patient problems: Unspecified Infection

  MAUDE report 17459950 ↗