LCP 224.758Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982158727), received between Mar 20, 2019 and Aug 26, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). IT WAS REPORTED THAT A CLINICAL ADVERSE EVENT WAS RECEIVED FOR LOSS OF FRACTURE REDUCTION. TREATMENT/IMPACT: RECOMMENDED FOLLOW-UP WITH PLASTIC SURGERY AND INFECTIOUS DISEASE. RECOMMEND CONTINUED USE OF TELFA AND SILVADENE DRESSINGS OVER THE HEALING WOUNDS. THE PATIENT WILL REMAIN NON-WEIGHTBEARING OF THE LEFT LOWER EXTREMITY. THIS REPORT IS FOR ONE (1) 4.5MM/3.5MM LCP METAPHYSEAL PLATE 13 HOLES. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20066266 ↗
• InjuryMar 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF TIBIA, THE LOCKING COMPRESSION PLATE (LCP) METAPHYSEAL PLATE 13 HOLES WAS PLACED ON THE MIDSHAFT TIBIA TO PROXIMAL HALF. THE NON-UNION AND WEIGHT BEARING CAUSED THE PLATE TO SNAP POSTOPERATIVELY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM/3.5MM LCP METAPHYSEAL PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 8437040 ↗