LCP 02.001.304Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027573), received between Mar 1, 2017 and Mar 1, 2017 — 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.

• InjuryMar 1, 2017Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WITH HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN DISTAL FEMORAL PLATE AND PATIENT PAIN. THE PATIENT INITIALLY UNDERWENT AN UNKNOWN PROCEDURE AND WAS IMPLANTED WITH THE PLATE AND SCREWS ON AN UNKNOWN DATE. UPON CLINICAL FOLLOW-UP ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. AN UNKNOWN DIAGNOSTIC PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE THAT REVEALED THE BROKEN PLATE. THE PATIENT UNDERWENT A DISTAL FEMUR PLATE AND SCREW REVISION ON (B)(6) 2017. THE SURGEON REMOVED THE BROKEN PLATE WITHOUT COMPLICATIONS. THERE WERE SEVERAL UNKNOWN SCREWS THAT WERE ALSO REMOVED, HOWEVER, TWO (2) OF THE SCREWS BROKE AT THE HEAD, MAKING IT DIFFICULT TO REMOVE THE REMAINDER OF THE SCREW SHAFT. THE TWO (2) BROKEN SCREW SHAFTS WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS REVISED WITH ONE (1) NEW PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED WITH NO OTHER COMPLICATIONS OR SURGICAL TIME DELAY. THE PATIENT¿S POSTOPERATIVE STATUS WAS STABLE. THIS COMPLAINT IS RELATED TO COMPLAINT, (B)(4), WHICH ADDRESSES AND REPORTS THE TWO (2) BROKEN UNKNOWN SCREWS AND RETAINED FRAGMENTS. THIS REPORT ADDRESSES THE EVENT OF PATIENT PAIN AND THE BRO

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 6367931 ↗

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.