LCP 239.955Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982163493), received between Apr 13, 2018 and Jun 18, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN PROCEDURE THAT LOCKING SCREW DID NOT ENGAGE WITH ONE OF THE COMBO HOLES IN THE PLATE. A NON-LOCKING SCREW WAS USED IN ITS PLACE. THE LOCKING SCREW WAS FOUND NOT BE THE PROBLEM AS THE SAME SCREW ENGAGED A DIFFERENT LOCKING HOLE. TWO NEW DRILL BITS WERE ALSO FOUND TO BE DULL AND HEATED UP THE BONE EXCESSIVELY WHEN TRYING TO DRILL WITH THEM. NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 3 DEVICE. THIS REPORT IS FOR ONE (1) 3.5 LCP MED PROXIMAL TIB PL 4H/LFT 93 THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029018 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2017. THE PATIENT RETURNED TO CLINIC WITH FAILURE OF OPEN REDUCTION OF INTERNAL FIXATION(ORIF) MEDIAL PROXIMAL TIBIA, DUE TO INFECTION, INFLAMMATION, AND NONUNION. PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6) 2018. THE SURGEON EVACUATED JOINT FLUID AND REMOVED ONE (1) 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 4H/LEFT 93MM, THREE (3) 3.5MM CORTEX SCREWS, AND FOUR (4) 3.5MM LOCKING SCREWS. ALL HARDWARE WAS INTACT. SURGEON STATED HE HAD DONE A LATERAL LIGAMENT REPAIR ON PATIENT AND THE WOUND HAD DEHISCED ON THAT SIDE. HIS REPAIR HAD FALLEN APART AND THE PATIENT STARTED GOING INTO VARIX WHICH MOST LIKELY CAUSED THE ORIF ON THE MEDIAL SIDE TO FAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS WAS REPORTED AS OK/COMPLETE. THIS REPORT IS FOR ONE (1) 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 4H/LEFT 93MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7428473 ↗