LCP 04.112.092Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982103024), received between Apr 10, 2017 and Apr 10, 2017 — classified as 1 malfunction.

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

• MalfunctionApr 10, 2017Break; Break

  IT WAS REPORTED THAT A 3.5MM TITANIUM (TI) LOCKING COMPRESSION PLATE (LCP) BROKE DURING AN INITIAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT CLAVICLE PROCEDURE ON (B)(6) 2017. WHILE CONTOURING THE PLATE TO PATIENT ANATOMY USING UNKNOWN QUANTITY OF CLAVICLE BENDING PRESS, THE PLATE BROKE INTO TWO PIECES. IT WAS A CLEAN BREAK AND NO FRAGMENTS WERE GENERATED. THE PLATE WAS EASILY RETRIEVED. IT IS UNKNOWN IF THE CONTOURING WAS PERFORMED OVER THE PATIENT OR AT THE BACK TABLE HOWEVER, NO FRAGMENTS/RESIDUALS WERE FOUND IN THE PATIENT. A COMPETITOR¿S PLATE AND COMPETITOR'S CLAVICLE BENDING PRESS WERE USED TO SUCCESSFULLY COMPLETE SURGERY. THERE WAS A FIVE MINUTES SURGICAL DELAY DUE TO GETTING ANOTHER PLATE. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CLAVICLE BENDING PRESS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SUPERIOR CLAVICLE PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6478134 ↗