LCP 224.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982158581), received between Jul 18, 2017 and May 30, 2019 — classified as 3 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 16, 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 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REMOVAL OF NARROW LOCKING COMPRESSION PLATE (LCP) PLATE DUE TO PLATE BREAKAGE. DATE OF ORIGINAL IMPLANT WAS FOUR (4) YEARS AGO. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5 MM NARROW LCP® PLATE 12 HOLES/224 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8656031 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A NARROW LOCKING COMPRESSION PLATE WITH 12 HOLES BROKE. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. SURGICAL AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP® PLATE 12 HOLES/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7842100 ↗
• InjuryJul 18, 2017Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN PLATE AND NON-UNION. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, THREE YEARS PRIOR. PATIENT IS LABOR WORKER AND STARTED WORKING BEFORE BONE HEALED. THE PLATE HAD BROKEN DOWN THE MIDDLE, OVER A NON-UNION OF THE RIGHT HUMERUS. REMOVED HARDWARE INCLUDED THE PLATE (BROKEN), THREE CABLES (INTACT) AND TEN SCREWS (INTACT). THE PATIENT WAS REVISED TO A METAPHYSEAL PLATE AND SCREWS AND 3 CABLES WITH BONE GRAFTING. THERE WERE NO REPORTED SURGICAL DELAYS, NO FRAGMENTS INVOLVED AND NO ADDITIONAL X-RAYS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 1.7MM CABLE WITH CRIMP 750MM (PART # 298.801.01, LOT # UNKNOWN, QUANTITY # 3), 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM (PART # 212.208, LOT # UNKNOWN, QUANTITY # 3), 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 30MM (PART # 212.209, LOT # UNKNOWN, QUANTITY # 4), 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 32MM (PART # 212.210, LOT # UNKNOWN, QUANTITY # 3). THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP® PLATE. THIS IS REPORT 1 OF 1

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6722299 ↗