ROI-C MC1320PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663016124), received between Feb 2, 2021 and Nov 22, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023Fracture; Device Slipped; Fracture; Device Slipped

  IT WAS REPORTED THAT AN ROI-C CAGE WOBBLED IN THE DISC SPACE WHEN THE FIRST ANCHORING PLATE WAS INTRODUCED. THE CAGE WAS REMOVED AND WAS FOUND TO BE BROKEN. A NEW CAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 15-MINUTE DELAY WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191924 ↗
• MalfunctionMar 6, 2023Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT AN ROI-C CAGE WAS NOT WELL-POSITIONED THEN IT MOVED ANTERIORLY AND INTO THE CORTICAL RIM OF THE VERTEBRAL BODY WHILE THE SUPERIOR PLATE WAS BEING INSTALLED. THE CAGE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MINUTE DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484877 ↗
• MalfunctionFeb 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF ROI-C CAGE BROKE OFF WHILE ANCHORING PLATES WERE BEING HAMMERED INTO THE CAGE. THE CAGE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11268011 ↗