LCP 02.112.138Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982033895), received between Mar 1, 2017 and Oct 31, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON NOTED THAT THE DISTAL FIBULA PLATE WAS PROMINENT DISTALLY ON THE PATIENT. THERE WAS NO SURGICAL DELAY, THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADVERSE EVENTS WERE REPORTED TO OCCUR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/RIGHT/86MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699250 ↗
• MalfunctionOct 29, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE SURGEON COMMENTED THAT THE DISTAL FIBULA PLATE WAS TOO BULKY AND DECIDED TO REMOVE IT IN EXCHANGE FOR A 1/3 TUBULAR PLATE ON THE FIBULA. WHILE USING A 1/3 TUBULAR ON THE MEDIAL SIDE OF THE TIBIA, THE SURGEON COULD NOT GET THE LOCKING MECHANISM TO FUNCTION, HOWEVER, IT WAS POSSIBLE THAT THE LOCKING HOLE WAS DEFORMED BY PUTTING A PREVIOUS NON-LOCKING SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7/3.5 LCP LATERAL DSTL FIB PL 4H/RT/86. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719671 ↗
• MalfunctionMar 20, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OSTEOSYNTHESIS OF THE LEFT DISTAL PERONE THAT AN ADVERSE EVENT OCCURED. WHEN THE SURGEON REQUESTED THE PLAQUE, THE OPPOSITE LATERALITY PLAQUE WAS PASSED AND PLACED IN THE PATIENT. CONCOMITANT MEDICAL PRODUCT: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/RIGHT/86MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860444 ↗
• InjuryMar 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD HARDWARE REMOVAL ON (B)(6) 2017 DUE TO BEING SEPTIC. PATIENT WAS INITIALLY IMPLANTED WITH A 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP), FOUR 2.7MM LOCKING SCREWS, AND THREE 3.5MM CORTEX SCREWS IN (B)(6) 2016 FOR A BROKEN DISTAL FIBULA. THERE WERE NO REPORTED COMPLICATIONS DURING THE INITIAL SURGERY. IT IS UNKNOWN HOW THE INFECTION WAS DISCOVERED AND HOW IT WAS CONFIRMED. THE LOCATION AND TYPE OF INFECTION IS UNKNOWN. ON THE DAY OF THE REMOVAL SURGERY, IN ADDITION TO BEING SEPTIC, PATIENT WAS PRESENTED WITH RENAL FAILURE. IT IS UNKNOWN IF PATIENT HAD RENAL FAILURE PRIOR TO THE INITIAL IMPLANTATION OF THE HARDWARE. SURGEON STATED THAT THE PATIENT WAS IN A STATE OF DYING. ALL HARDWARE WAS REMOVED INTACT. THERE WERE NO ISSUES WITH THE HARDWARE. NO NEW HARDWARE WAS IMPLANTED. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT REQUIRING INTERVENTION. NO SURGICAL DELAY REPORTED. PATIENT STATUS/OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) LCP LATERAL DISTAL FIBULA PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Renal Failure; Unspecified Infection

  MAUDE report 6367935 ↗