LCP 240.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982164551), received between Mar 30, 2018 and Jul 24, 2020 — classified as 3 injuries.

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 16, 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.

• InjuryJul 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION AND DELAYED HEALING SECONDARY TO A BROKEN LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE. DURING THE REVISION PROCEDURE ALL THE ORIGINAL IMPLANTS WHICH CONSIST OF 1LCP TIBIA PLATE, 3 5.0MM LOCKING SCREWS, 6 4.5MM CORTEX SCREWS AND 2 CANCELLOUS SCREWS WERE ALL REMOVED THEN THE PATIENT WAS REVISED TO TIBIAL NAIL EX. THERE WERE FRAGMENTS GENERATED BUT WERE REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH MINIMAL DELAY. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN 5.0MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3), UNKNOWN 4.5MM CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 6), UNKNOWN CANCELLOUS SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR 1 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-RIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10323119 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4) , A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-RIGHT. THIS IS REPORT 9 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497927 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ELBOW AND TIBIA ON (B)(6) 2017. ON UNKNOWN DATE PATIENT REPORTED EXPERIENCING PAIN AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. HARDWARE REMOVED INCLUDED ONE (1) 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) OLECRANON PLATE, SIX (6) LOCKING SCREWS, TWO (2) CORTEX SCREWS, ONE (1) 4.5MM LCP PROXIMAL TIBIA PLATE, SEVEN (7) LOCKING SCREWS, AND TWO (2) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) LCP PROXIMAL TIBIA PLATE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7387086 ↗