ROI-C CMC1422PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663023429), received between May 9, 2022 and Sep 18, 2025 — classified as 2 malfunctions.

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. 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.

• MalfunctionSep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE WAS DEFORMED AND AN ROI-C CAGE FRACTURED DURING SURGERY. A SECOND PLATE AND CAGE WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088579 ↗
• MalfunctionMay 9, 2022Migration; Migration

  IT WAS REPORTED THAT A BROKEN ROI-C ANCHORING PLATE WAS FOUND IN AN X-RAY TAKEN APPROXIMATELY 6 MONTHS POSTOPERATIVELY. ALSO, THE SURGEON BELIEVES THE CAGE MAY HAVE SUBSIDED. THE CAGE WAS PLACED AT LEVEL C5/6 AND THE PLATE BROKE AT C6. AT THIS TIME, THERE ARE NO REPORTED PLANS FOR REVISION SURGERY, BUT THE PATIENT IS FEELING SOME NUMBNESS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Numbness

  MAUDE report 14337308 ↗