LCP 223.406Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982157584), received between May 24, 2018 and May 14, 2024 — classified as 2 injuries.

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.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN COLLABORATION WITH DEPUY SYNTHES TOGETHER WITH (B)(6) HOSPITAL A RETROSPECTIVE DATA COLLECTION WAS PERFORMED ON PATIENTS WHO RECEIVED LOCKING COMPRESSION PLATES. DATES ARE NOT INCLUDED IN THE DATA DUE TO PRIVACY RESTRICTIONS. PATIENT #10: 51-YEAR-OLD MALE WAS IMPLANTED WITH LCP METAPHYSEAL PLATES 3.5 (223.406) IN ANKLE WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION DEVICE. POST-OPERATIVE COMPLICATION: INFECTION EXPERIENCED 12 WEEKS POST-OP RELATED TO BOTH SYNTHES DEVICE AND PROCEDURE. TREATMENT: SURGICAL TREATMENT FOR I&D AND HARDWARE REMOVAL OF PLATE AND SCREWS PERFORMED 12 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR ONE 3.5MM LCP METAPHYSEAL PLATE 6 HOLES FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19315957 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL OF THE LOCKING COMPRESSION PLATE (LCP) METAPHYSEAL PLATE AND FOUR (4) CORTEX SCREWS ON (B)(6) 2018 DUE TO NON-UNION. THE PATIENT WAS REVISED TO A NEW PLATE. THE SURGEON ALSO USED BONE VOID (VIVIGEN 5CC). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A 3.5MM LCP® METAPHYSEAL PLATE 6 HOLES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7539976 ↗