ROI-C CMC1431PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663023474), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE THE SURGEON WAS INSTALLING THE SECOND PLATE INTO A CAGE AT LEVEL C4/5, THE CAGE BROKE AND DETACHED FROM THE INSERTER. THE SURGEON HAD PREPPED THE PATH OF THE SECOND PLATE WITH THE USE OF AN AWL TO MAKE A PATH FOR IT. THIS WAS UNSUCCESSFUL. THE PLATE AND CAGE WERE REMOVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED WITH ANOTHER CAGE AND PLATES OF THE SAME SIZES. THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589062 ↗