LCP 424.758Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982217059), received between Feb 2, 2024 and Feb 2, 2024 — 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE MALE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY. AFTER THE FIRST SURGERY, ON (B)(6) 2024, IT WAS FOUND OUT THAT A TREATED BONE WAS MISALIGNED DUE TO POOR BONE UNION CONDITION. THEREFORE, A REMOVAL FOR FIXED SCREWS AND A REDUCTION PROCESS ARE SCHEDULED FOR (B)(6) 2024, AND THE CURRENT PLATE WILL BE REUSED FOR OSTEOSYNTHESIS ON THE SAME DAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LCP METAPHYSPL 3.5/4.5/5 BROAD 5+8HO L20. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18629300 ↗