LCP 02.112.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982033932), received between Feb 5, 2018 and Feb 15, 2019 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, LOCKING COMPRESSION PLATE (LCP) HOOK PLATE THREE HOLE, UNKNOWN SIX (6) CORTEX SCREWS AND UNKNOWN FOUR (4) LOCKING SCREWS DUE TO INFECTION AND NON UNION WITH SIGNIFICANT BONE LOSS. ALL DEVICES WERE REMOVED SUCCESSFULLY AND AN UNKNOWN EXTERNAL FIXATION WAS IMPLANTED. ORIGINAL PROCEDURE WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ANKLE SURGERY ON (B)(6) 2018 AT THE SAME FACILITY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99MM. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8345219 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2018 DUE TO PAIN AND DISCOMFORT. IN ADDITION TO THE PAIN AND DISCOMFORT, THE PATIENT REPORTED BEING ABLE TO FEEL THE HARDWARE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) PLATES, TWO (2) 4-HOLE VA MEDIAL DISTAL TIBIA, EIGHT (8) LOCKING SCREWS, SIX (6) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, TWO (2) WASHERS AND A K-WIRE ON AN UNKNOWN DATE. ALL OF THE HARDWARE WERE REMOVED DURING THE APRIL 4 PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES 8 DEVICES. THIS REPORT IS 1 OF 8 FOR (B)(4).

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 7455812 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT SURGERY TO TREAT A LEFT ANKLE FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 2.7 MM/3.5 MM LCP LATERAL DISTAL PLATE AND TEN (10) SCREWS. IT WAS UNKNOWN TO THE SURGEON IF THE PATIENT WAS ALLERGIC TO METAL AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY THE PATIENT FELT SOME SOFT TISSUE IRRITATION AND THIS WAS DISCOVERED TO BE A REACTION TO METAL ALLERGY. THE SURGEON THEN DECIDED TO REMOVE ALL IMPLANTED DEVICES AND THE CONSTRUCT WITH ALL DEVICES INTACT WAS REMOVED ON (B)(6) 2018. INTRA-OPERATIVE X-RAYS TAKEN SUGGESTED THAT THE FRACTURE HAD COMPLETELY HEALED. THE REMOVAL OF PLATE AND SCREWS CONSTRUCT WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 2.7 MM/3.5 MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99 MM. THIS IS REPORT 1 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7242148 ↗