LCP 241.171Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982166043), received between Jun 30, 2017 and Jun 30, 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 (K000684); 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 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.

• InjuryJun 30, 2017Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF A LEFT ANKLE FUSION ON (B)(6) 2017 DUE TO THE PLATE BREAKING POST-OPERATIVELY AT THE LEVEL WHERE THE HEAD OF THE PLATE MEETS THE SHAFT. THE HARDWARE FAILURE WAS DETECTED BY X-RAY ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE PATIENT HAD PAIN OR DISCOMFORT RELATED TO THE BROKEN PLATE. THE SURGEON EASILY REMOVED THE BROKEN PLATE AND THE PLATE FRAGMENTS. EIGHT UNKNOWN 3.5MM CORTEX SCREWS WERE REMOVED WHOLE AND INTACT. ONE UNKNOWN 3.5MM CORTEX SCREW WAS BROKEN, THE HEAD OF THE SCREW WAS REMOVED BUT THE SCREW FRAGMENT WAS RETAINED BECAUSE THE SURGEON DID NOT THINK IT NEEDED TO BE RETRIEVED. NO SURGICAL DELAY WAS REPORTED. THE NEW HARDWARE IMPLANTED IN THE PATIENT CONSIST OF A 4.5MM LOCKING COMPRESSION PLATE (LCP) ANTERIOR ANKLE ARTHRODESIS PLATE AND SEVEN (7) SCREWS, OF WHICH FIVE WERE 4.5MM CORTEX SCREWS AND TWO WERE 6.5MM CANCELLOUS SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED STABLE. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 8) THIS REPORT IS FOR ONE (1) 3.56MM LCP PLATE. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6682103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,