LCP 224.561Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982158468), received between May 3, 2019 and May 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH LCP METAPHYSEAL PLATES 3.5, IN THE TIBIA, WITH DPS SCREWS AND WITH AN ADDITIONAL PLATES ADJUNCTIVE FIXATION DEVICES (1/3 TUBULAR LOCKING). AT 24- WEEKS POST-OP THE PATIENT EXPERIENCED IMPLANT PROMINENCE RELATED TO BOTH DEVICES. AT 52 WEEKS POST-OP THE PATIENT UNDERWENT HARDWARE REMOVAL OF THE PLATE AND SCREWS. THE PATIENT HAS RECOVERED. THIS REPORT INVOLVES ONE (1) 4.5MM NARROW LCP® PLATE 6 HOLES/116MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19279516 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF 4.5MM NARROW LOCKING COMPRESSION PLATE (LCP) 6 HOLES PLATE AND SIX (6) 4.5MM UNKNOWN CORTEX SCREW AS THE SURGEON WAS NOT PLEASED WITH THE RESULTS OF THE OPERATION. THE SURGEON PERFORMED DE-ROTATIONAL OSTEOTOMY ABOUT SIX (6) WEEKS AGO AND THE PATIENT WAS IMPLANTED WITH THE LOCKING COMPRESSION PLATE (LCP) SYSTEM. HOWEVER, DEFORMITY CORRECTION WAS NOT SUCCESSFULLY DONE, AND NEEDED CORRECTION. SO, THE SURGEON REMOVED THE PLATE AND THE UNKNOWN CORTEX SCREWS AND ADJUSTED THE OSTEOTOMY AND USED AN UNKNOWN FEMORAL RECON NAIL TO FIXATE. THERE WAS NO ALLEGATION AGAINST DEPUY SYNTHES DEVICES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP® PLATE 6 HOLES/ 116MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10432837 ↗
• InjuryMay 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT RIGHT DISTAL HUMERUS REVISION SURGERY DUE TO NON-UNION AND BROKEN PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE FOLLOWING DEVICES ON AN UNKNOWN DATE; ONE (1) 4.5MM/16MM NARROW LOCKING COMPRESSION PLATE (LCP) WITH 6 HOLES, TWO (2) 4.5 MM/ 32MM CORTEX SCREW SELF-TAPPING, ONE (1) 4.5MM/36MM CORTEX SCREW SELF-TAPPING, ONE (1) 5.0MM/28MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS, ONE (1) 5.0MM/30MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS, ONE (1) 5.0MM/32MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS, AND ONE (1) 5.0MM/36MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS. THE PLATE WAS BROKEN ON AN UNKNOWN DATE. THE DEVICES WERE EXPLANTED. PATIENT'S BROKEN HARDWARE WAS REPLACED WITH NEW HARDWARE FOR STABILITY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 4.5 MM/ 32MM CORTEX SCREW SELF-TAPPING (214.832, LOT#UNKNOWN, QUANTITY 2), 4.5MM/36MM CORTEX SCREW SELF-TAPPING (214.836, LOT#UNKNOWN, QUANTITY 1), 5.0MM/28MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS (212.208, LOT#UNKNOWN, QUANTITY 1), 5.0MM/30

  Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8578543 ↗