ROI-C CMC1322PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663023184), received between Jul 9, 2021 and Jan 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SECOND PLATE OF AN ROI-C CONSTRUCT COULD NOT BE INSTALLED WITHIN THE SPACER INTRA-OPERATIVELY. DURING INSTALLATION OF THE SECOND CONSTRUCT AT THE ADJACENT LEVEL, A PIECE OF THE ANTERIOR PORTION OF THE SPACER BROKE OFF AND WAS WEDGED IN THE CHANNEL BETWEEN THE SPACER AND THE PLATE; THE PIECE COULD NOT BE RECOVERED. THERE WAS A DELAY OF 30 MINUTES TO THE PROCEDURE, BUT THERE HAVE BEEN NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456320 ↗
• MalfunctionJul 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PLATE INSERTION, THE CAGE AND PLATE WERE DAMAGED INTRA-OPERATIVELY. A NEW CAGE AND PLATE WERE USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144797 ↗