ROI-C CMC1434PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663023504), received between Mar 10, 2023 and Sep 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964512 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964498 ↗
• MalfunctionMar 10, 2023Fracture; Fracture

  IT WAS REPORTED AN ROI-C CAGE WAS FOUND TO HAVE CRACKED WHEN THE INSERTER WAS TAKEN OFF AFTER THE PLATES WERE IMPLANTED INTRAOPERATIVELY. THE CAGE AND PATES WERE REMOVED AND REPLACED. THERE WAS A DELAY OF 20 MINUTES, BUT THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526187 ↗