LCP 02.112.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982032553), received between Sep 27, 2017 and Sep 27, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2017Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLAVICLE PLATE AND SCREWS WERE IMPLANTED ON A PATIENT ON AN UNKNOWN DATE IN (B)(6) 2017. THE PATIENT WAS NONCOMPLIANT POST-OPERATIVELY CAUSING DEVICE FAILURE. A PLATE HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO PATIENT NON-COMPLIANCE. A PLATE AND SCREWS WERE REVISED WITH NEW PLATES AND SCREWS. ALL THE EXPLANTED DEVICES WERE ALL INTACT WITH NO ALLEGATIONS AGAINST THEM. THERE WAS NO SURGICAL TIME DELAY AND NO PATIENT HARM REPORTED. THE PROCEDURE WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) 3.5MM LCP SUPERIOR ANTERIOR CLAVICLE PLATE WITH LATERAL EXTENSION-3 HOLE-RIGHT-69MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6898049 ↗