ROI-C MC1331PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663016209), received between Jun 22, 2021 and Jul 22, 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.

• MalfunctionJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C IMPLANT FRACTURED INTRA-OPERATIVELY WHILE INSERTING THE ANCHORING PLATE. IT WAS REPORTED THAT THE PLATE WAS STIFF AND CAUSED DIFFICULTY. THE SURGERY WAS COMPLETED USING ANOTHER CAGE AND PLATE WITHOUT PATIENT IMPACT.THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797502 ↗
• MalfunctionJun 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT A CAGE BROKE WHILE BEING DRIVEN IN. THE ANTERIOR PART OF THE CAGE WAS STUCK TO THE IMPLANT HOLDER AND THE REST OF THE CAGE WAS FIRMLY ANCHORED IN THE PATIENT. THE PART THAT WAS ANCHORED IN THE PATIENT WAS EXPLANTED WITHOUT ANY PROBLEMS AND THE A NEW CAGE WAS IMPLANTED. THE CAGE WAS IMPLANTED ACCORDING TO SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042104 ↗