LCP 02.001.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027559), received between May 8, 2018 and May 8, 2018 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K041911); they may or may not involve this specific model.

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.

• InjuryMay 8, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A PLATE AND SCREWS DUE TO POST-OPERATIVE PLATE BREAKAGE. THE 4.5MM LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE, 12 HOLES AND TEN (10) SCREWS; 4.0MM LOCKING AND 5.0MM CANNULATED LOCKING SCREWS WERE EASILY REMOVED INTACT. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT WAS INITIALLY IMPLANTED WITH THE HARDWARE ON AN UNKNOWN DATE. CONCOMITANT DEVICES REPORTED: 4.0MM LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.0MM CANNULATED LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7496473 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.