LCP 224.551Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982158444), received between Jun 22, 2017 and Jun 22, 2017 — 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 16, 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.

• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT ON (B)(6) 2016. INITIAL TREATMENTS INCLUDED MULTIPLE EXTERNAL FIXATION (EX-FIX) AT MULTIPLE ANATOMIC SITES, AS WELL AS TRAUMATIC AMPUTATION OF THE LOWER LEFT LEG. DURING THE FOLLOWING WEEKS PATIENT WAS RETURNED FOR SEVERAL SURGERIES WITH MULTIPLE SURGEONS TO TREAT FRACTURES OF THE LEFT FEMUR, RIGHT TIBIA, FOREARM, HAND, AND BI-LATERAL HUMERI. THE RIGHT HUMERUS WAS ORIGINALLY TREATED ON (B)(6) 2016 AND WAS LATER REVISED ON (B)(6) 2016 DUE TO NON-UNION. THIS REVISION IS ADDRESSED IN COM-(B)(4). PATIENT WAS AGAIN RETURNED TO SURGERY ON (B)(6) 2017 DUE TO HYPER-TROPHIC NON-UNION OF THE SAME RIGHT HUMERUS FRACTURE. DURING REVISION PROCEDURE, SURGEON REMOVED ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PLATE, ONE (1) 4.5MM NARROW LCP PLATE, FOUR (4) SMALL FRAGMENT SCREWS, AND FOUR (4) LARGE FRAGMENT SCREWS. ALL HARDWARE WAS REMOVED INTACT. PATIENT WAS REVISED TO A TEMPORARY DEVICE AND AN ANTIBIOTIC CEMENT SPACER TO INITIATE THE MASQUELET TECHNIQUE. THE PRESENCE OF INFECTION HAS NOT BEEN DETERMINED OR RULED OUT. PATIENT WILL REQUIRE AT LEAST ONE ADDITIONAL SURGERY FOR THIS FRACTURE. BONE GRAFTING AND DEFINITIVE FRACTURE FIX

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6660019 ↗