NA 55-08216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540602718), received between Mar 25, 2020 and Mar 25, 2020 — classified as 1 injury.

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. 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.

• InjuryMar 25, 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 SURGEON THAT A PATIENT REQUIRED A REVISION SURGERY DUE TO EXPERIENCING PAIN AND HAVING PUS SECRETIONS APPROXIMATELY 4-5 WEEKS AFTER INITIAL IMPLANTATION WITH AN IMPLANT. THE ORIGINAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY, BUT DURING THE REVISION SURGERY IT WAS FOUND THAT THE SCREWS HAD LOOSENED, CALCIFICATION FORMED NEAR THE PLATE, AND A PATIENT SWAB TESTED AS MRSA POSITIVE. THE PLATE WAS REMOVED.

  Patient problems: Abscess; Bacterial Infection; Pain

  MAUDE report 9876841 ↗