ROI-C MC1343PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663016292), received between Aug 9, 2021 and Jul 17, 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.

• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE REMOVAL AREA OF THE ROI-C PEEK CAGE FRACTURED DURING CAGE IMPLANTATION. WHEN THE CAGE WAS INSERTED INTO THE DISC SPACE BEFORE INSERTING THE PLATE, THE SURGEON FOUND THE FRACTURED PIECE IN THE PATIENT. THE CAGE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM AND ONLY A 10 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536070 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C CAGE WAS FOUND TO BE BROKEN INTRA-OPERATIVELY VIA X-RAY WHEN THE SECOND PLATE WOULD NOT INSTALL CORRECTLY. THE CAGE AND FIRST PLATE WERE REMOVED AND REPLACED TO COMPLETE THE PROCURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982849 ↗
• MalfunctionAug 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OPERATION, A CAGE FRACTURED WHILE THE PLATE WAS BEING INSTALLED THROUGH IT. ALL PIECES OF THE CAGE WERE RETRIEVED AND THE SURGERY WAS COMPLETED WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294892 ↗