ROI-C CMC1443PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663023559), received between Oct 1, 2020 and Jan 6, 2021 — classified as 2 malfunctions.

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

• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT A PLATE WAS DIFFICULT TO INSTALL INTO THE MATING CAGE AND THE CAGE WAS FOUND TO BE BROKEN AFTER BOTH PIECES WERE REMOVED INTRA-OPERATIVELY. A NEW CAGE WAS INSTALLED, THE AWL WAS USED TO CREATE THE PATHWAY FOR THE PLATE, AND A NEW PLATE WAS INSTALLED WITHOUT ISSUE. THERE WERE NO REPORTED PATIENT IMPACTS.THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124109 ↗
• MalfunctionOct 1, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROI-C ANCHORING PLATE WAS STUCK AND COULD NOT ADVANCE FURTHER INTO THE ROI-C CAGE. A WIDER 15X5 CAGE AND ALTERNATE ANCHORING PLATES WERE USED AS A REPLACEMENTS FOR SURGERY COMPLETION. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613763 ↗