LCP 223.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982157638), received between Dec 19, 2017 and Jan 28, 2021 — classified as 2 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 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.

• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL WITH 3.5 LCP METAPHYSEAL PLATE AND 3.5 CORTEX SCREWS IN QUESTION. THE PATIENT HAD AN INITIAL PROCEDURE PERFORMED AT AN OUTSIDE HOSPITAL IN (B)(6) OF 2020 FOR A HUMERUS NON-UNION. THE PATIENT WAS TRANSFERRED TO A SURGEON ON (B)(6) 2021 AND UPON LABORATORY DIAGNOSIS WAS DETERMINED TO HAVE AN INFECTION AND THE HARDWARE WAS REMOVED WITHOUT ISSUE ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 3.5MM LCP® METAPHYSEAL PLATE 11 HOLES. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11244005 ↗
• InjuryDec 19, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A PLATE AND SCREWS ON (B)(6) 2017 DUE TO BROKEN PLATE, NON-UNION, AND SEPTIC INFECTION. THE PATIENT PRESENTED WITH A BROKEN 3.5 MM LOCKING COMPRESSION PLATE (LCP) METAPHYSEAL PLATE, 11 HOLE PLATE IN THE LEFT MID-SHAFT ULNA. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE PLATE AND NINE (9) SCREWS (SIX (6) 3.5 MM CORTEX SCREWS IN THE PLATE, ONE (1) INDEPENDENT LAG SCREW, AND TWO (2) 3.5 MM LOCKING SCREWS) WERE SUCCESSFULLY REMOVED, THERE WERE NO FRAGMENTS. A CHISEL WAS USED TO REMOVE BONE GROWTH FROM OVER THE SCREWS AND PLATE. THE AREA WAS DEBRIDED AND IRRIGATED. A NEW PLATE WAS IMPLANTED; THE SURGEON CUT THE PROXIMAL TIP OF THE PLATE TO ACCOMMODATE THE PATIENT ANATOMY. RELEVANT SCREWS WERE USED FOR FIXATION: VARIABLE ANGLE ELBOW SET AND LCP SMALL FRAGMENT SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A 3.5 MM LCP METAPHYSEAL PLATE. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7130842 ↗