VA-LCP 02.117.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982035721), received between Apr 5, 2018 and Apr 5, 2018 — 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.

• InjuryApr 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN INCISION AND DRAINAGE (I&D) OF A SURGICAL WOUND AND UPON X-RAY OF THE HARDWARE, A BROKEN PLATE WAS NOTED OF THE POSTEROLATERAL PLATE OF THE DISTAL HUMERUS. THE PATIENT WAS ONLY 8 WEEKS OUT FROM SURGERY AND THE SURGEON DECIDED TO REVISE THE PATIENT AND REMOVE THE BROKEN PLATE. THE PATIENT WAS REVISED TO NEW HARDWARE ON AN UNKNOWN DATE. A SURGICAL DELAY OF UNKNOWN TIME WAS NOTED. PATIENT STATUS IS UNKNOWN. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7400508 ↗