NA 55-15514Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540356314), received between Apr 1, 2020 and May 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL WITH A BROKEN IMPLANTED PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043476 ↗
• InjuryApr 1, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POSSIBLE POST-SURGICAL INFECTION OVER A MONTH AFTER INITIAL IMPLANTATION WITH AN IMPLANT. THE ORIGINAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY, BUT A REVISION SURGERY OCCURRED TO REMOVE THE PLATE. THERE HAVE BEEN NO ISSUES FOUND SINCE THEN.

  Patient problems: Unspecified Infection

  MAUDE report 9913453 ↗