ROI-C MC1332PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663016216), received between Jan 20, 2021 and Apr 11, 2024 — 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.

• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE BROKE APART DURING INSERTION INTRA-OPERATIVELY. IT WAS REMOVED AND REPLACED WITH A DIFFERENT IMPLANT TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 5 MINUTES, BUT THERE WERE NO IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093375 ↗
• MalfunctionApr 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C PLATE WAS DIFFICULT TO INSTALL THEN BENT AND A CAGE BROKE INTRA-OPERATIVELY. THEY WERE BOTH REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746661 ↗
• MalfunctionJan 20, 2021Fracture; Fracture

  THE ROI-C PEEK FRACTURED DURING THE CAGE INSERTION PROCESS. A NEW IMPLANT WAS USED TO COMPLETE THE OPERATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11201582 ↗