LCP 226.641Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982159212), received between Aug 11, 2020 and Feb 22, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• InjuryFeb 22, 2023Migration; Migration

  HOLD RH 2.22.23IT WAS REPORTED THAT SURGEON REVISED A FEMUR FRACTURE ON (B)(6) 2023 THAT FAILED. A LOCKING SCREW APPEARS TO HAVE POSSIBLY BEEN PUT IN A NON LOCKING HOLE AND THE PLATE PULLED OFF THE BONE. ONE OF THE 5.0 LOCKING SCREW WAS BROKEN, AND THE SHAFT FRAGMENT REMAINED IN THE PATIENT. THE HARDWARE WAS PLACED IN (B)(6) 2021. ADDITIONALLY DURING THIS REVISION, THE TABLE TOP PLATE BENDER DID NOT WORK PROPERLY BECAUSE THE SCREW THAT SECURES ANVIL WOULD NOT SCREW IN. IT IS CURRENTLY UNKNOWN IF THE THREADS ON THE SCREW WERE DAMAGED OR THREADS ON THE PLATE BENDER. MORE INFORMATION WILL BE AVAILABLE AFTER IT IS INSPECTED POST OPERATIVELY. THIS REPORT IS FOR ONE (1) 4.5MM BROAD LCP PLATE 14 HOLES/260MM THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16418065 ↗
• InjuryOct 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PLATE WAS IMPLANTED ON AN (B)(6) 2022, BUT BROKE POST-OPERATIVELY ON AN UNKNOWN DATE. A REVISION SURGERY OCCURRED ON (B)(6) 2022 AND A NEW PLATE IMPLANTED. THE SECOND PLATE ALSO BROKE POST-OPERATIVELY. A SECOND REVISION SURGERY OCCURRED ON (B)(6) 2022 AND THE SECOND BROKEN PLATE WAS REMOVED. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. THIS COMPLAINT CAPTURES THE RUPTURE OF THE SECOND PLATE IMPLANTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN LCP PLATE.

  Patient problems: Insufficient Information

  MAUDE report 15668669 ↗
• InjuryOct 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED A PLATE WAS IMPLANTED ON AN (B)(6) 2022, BUT BROKE POST-OPERATIVELY ON AN UNKNOWN DATE. A REVISION SURGERY OCCURRED ON (B)(6) 2022 AND A NEW PLATE IMPLANTED. THE SECOND PLATE ALSO BROKE POST-OPERATIVELY. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. THIS COMPLAINT CAPTURES THE RUPTURE OF THE FIRST PLATE IMPLANTED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN LCP PLATE.

  Patient problems: Insufficient Information

  MAUDE report 15668411 ↗
• InjuryAug 11, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020 DUE TO PLATE BREAKAGE. PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2020 FOR FEMUR OSTEOSYNTHESIS. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10393163 ↗