LCP 02.112.518Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982034557), received between Jun 23, 2015 and Mar 12, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMar 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE INSERTING A DISTAL TIBIA PLATE, THE AIMING ARM WAS MISSING THE PROXIMAL HOLES. AFTER THE CASE IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH THE AIMING ARM AND IT IS POSSIBLE THAT THE RIGHT SIDE AIMING ARM WAS EITHER DAMAGED/BENT. ONCE THE PROBLEM WAS IDENTIFIED, THE SURGERY PROCEEDED AND WAS SUCCESSFULLY FINISHED. THE SURGERY WAS DELAYED FOR 15 MINUTES. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/RIGHT/161MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477500 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MALUNION AND INFECTION. MOREOVER, THE PATIENT HAD EXPERIENCED DELAYED HEALING. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDIAL DISTAL TIBIAL PLATE, THREE (3) UNKNOWN 3.5MM LOCKING SCREWS, TWO (2) UNKNOWN 3.5MM CORTEX SCREWS, ONE (1) 2.7MM LCP PLATE, FOUR (4) UNKNOWN 2.7MM CORTEX SCREWS AND TWO (2) UNKNOWN 2.7MM LAG SCREWS ON AN UNKNOWN DATE. DURING REVISION, ALL HARDWARE WERE SUCCESSFULLY REMOVED AND THE PATIENT WAS REVISED WITH 3.5MM CORTEX SCREW WITH WASHER AND A VARIABLE-ANGLE (VA) ANTEROMEDIAL DISTAL TIBIA PLATE. PATIENT OUTCOME IS UNKNOWN. THE COMPLAINT INVOLVES 13 DEVICES. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 2 SEPARATE COMPLAINTS : (B)(4). (B)(4) CAPTURES THE POST-OP EVENT DUE TO MALUNION AND INFECTION WHILE (B)(4) CAPTURES THE INTRAOPERATIVE EVENT WHEREIN THE TIP OF THE TWO (2) STARDRIVE SCREWDRIVER SHAFTS WERE TWISTED ON FINAL TIGHTENING OF THE SCREWS. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS 1 OF 9 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8876326 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE IMPLANTATION ON (B)(6), OF AN UNKNOWN YEAR. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDIAL DISTAL TIBIA PLATES, LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATES WITH COLLAR, AND AN UNKNOWN NUMBER OF UNKNOWN SCREWS. THE REMOVAL OF DEVICES WERE DUE TO INFECTION AND TISSUE SLOUGHING. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/RIGHT/161MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7952035 ↗
• InjuryJun 23, 2015Break

  IT WAS REPORTED THAT A PATIENT HAD A REMOVAL OF AN EXTERNAL FIXATOR AND AN OPEN REDUCTION INTERNAL FIXATION OF THEIR RIGHT ANKLE. A LOCKING DISTAL TIBIAL PLATE WAS INSERTED AT THAT TIME. THE PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF HER CAST BEING TOO TIGHT. X-RAYS WERE TAKEN AT THE TIME AND READ AS NORMAL. THE NEXT DAY A RADIOLOGIST READ THE X-RAY AND REPORTED THAT THE DISTAL TIBIAL PLATE WAS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 4861863 ↗