LCP 426.641Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982217295), received between Sep 25, 2018 and Jul 11, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 11, 2022Break; Break

  DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE A LCP THAT HAD BEEN ORIGINALLY IMPLANTED AT ANOTHER HOSPITAL IN 2021 FOR A FEMUR SHAFT FRACTURE. NO PATIENT CONSEQUENCE OR CLINICAL OUTCOME WAS EXPERIENCED. THIS REPORT IS FOR A 4.5MM TI BROAD LCP® PLATE 14 HOLES/260MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14976799 ↗
• InjurySep 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT IMPLANT PROCEDURE. POST-OPERATIVE, ON (B)(6) 2018, PATIENT UNDERWENT AN UNKNOWN PROCEDURE TO TREAT AN UNCONSOLIDATED FRACTURE. PATIENT WAS DIAGNOSED WITH PSEUDARTHROSIS AND OSTEOMYELITIS. A DEFORMITY OF THE LIMB WAS NOTICED BY THE SURGEON AND AN X-RAY ON THE AFFECTED SITE REVEALED A BROKEN PLATE. DURING THE SURGERY, A LOCKING COMPRESSION PLATE (LCP) BROKEN IN TWO PARTS AND ELEVEN (11) INTACT SCREWS WERE REMOVED. A NEW LCP WAS IMPLANTED IN THE FEMUR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. THIS INCIDENT INVOLVES TWELVE (12) DEVICES. (B)(4) CAPTURES TEN (10) DEVICES AND (B)(4) CAPTURES REMAINING TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE (LCP). THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 7906676 ↗