LCP 02.112.203Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982034373), received between Jul 6, 2020 and Jul 6, 2020 — 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 18, 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.

• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF THE LOCKING COMPRESSION PLATING SYSTEM (LCP) OF THE DISTAL TIBIA DUE TO INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH AN LCP SYSTEM ON (B)(6) 2018. THE SURGEON COMMENTED THAT THE PATIENT HAD DEVELOPED SKIN ULCERS EARLY ON, WHICH CAUSED INFECTION FROM WEARING HIS POST-OP BOOT TOO TIGHT. THE HARDWARE WAS REMOVED, AND THE REMOVAL SURGERY WAS COMPLETED. THE PATIENT IS OK. CONCOMITANT DEVICES REPORTED: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM (PART NUMBER 241.351, LOT UNKNOWN, QUANTITY 1); 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT (PART NUMBER 02.118.205, LOT UNKNOWN, QUANTITY 1); SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 11); SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN QUANTITY 9). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4) AND (B)(4). (B)(4)CAPTURES THE 10 OF 23 DEVICES, (B)(4) CAPTURES THE 10 OF 23 DEVICES, AND (B)(4) CAPTURES THE 3 OF 23 DEVICES. THIS REPORT INVOLVES ONE (1) 3.5MM LCP DISTAL TIBIA T-PLATE 3 HOLE/64MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Ulcer; Unspecified Infection

  MAUDE report 10233231 ↗