ROI-C CMC1451PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663023597), received between Aug 12, 2022 and Aug 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionAug 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE AND PLATE FRACTURED INTRA-OPERATIVELY. THE CAGE FRACTURED ON THE ANTERIOR SURFACE WHERE THE PLATES SNAP INTO PLACE; THE FRACTURE PIECE WAS RECOVERED. THE SECOND PLATE LOOKS TO HAVE FRACTURED. AN AWL WAS USED TO PRIOR TO INSTALLING THE FIRST PLATE AS THE PATIENT HAD HARD BONE, BUT IT WAS NOT USED PRIOR TO INTRODUCTION OF THE SECOND PLATE. THE FULL CONSTRUCT REMAINS IMPLANTED BECAUSE IT WAS WELL-POSITIONED. THERE WAS A SHORT DELAY WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218601 ↗