LCP 238.704Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982162113), received between May 23, 2018 and May 23, 2018 — 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.

• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON UNKNOWN DATE IN 2006. PATIENT WAS IMPLANTED WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) METAPHYSEAL PLATE, 3.5MM LCP MEDIAL DISTAL TIBIA PLATE, 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATE, FIFTEEN (15) 3.5MM LOCKING SCREWS, AND FIVE (5) 3.5MM CORTEX SCREWS. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION OF THE ANKLE. X-RAY TAKEN ON UNKNOWN DATE REVEALED ONE OF THE SCREWS WAS ALSO BROKEN. IT IS UNKNOWN IF THE BROKEN SCREW WAS A LOCKING OR CORTEX SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE THREE (3) PLATES AND NINETEEN (19) SCREWS EASILY. THE BROKEN SCREW WAS TREPHINED IN ORDER TO ACCOMMODATE REMOVAL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5MM LCP MEDIAL DISTAL TIBIA PLATE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7538938 ↗