ROI-C MC1314PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663016094), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON FELT THERE WAS A DIFFERENCE BETWEEN THE HEIGHT OF TWO DIFFERENT ROI-C TRIAL FOOTPRINTS, SO ELECTED TO PLACE A 1 MM TALLER CAGE. THEN IMMEDIATELY POST-OPERATIVELY, THE PATIENT FELT UNWELL, HAD DIFFICULTY BREATHING, AND HEAVY BLEEDING. THE PATIENT WAS RETURNED TO THE OR WHERE THE CAGE WAS REMOVED, THE AREA AND CLOT WERE CLEANED OUT, AND A NEW CAGE WAS INSTALLED SO THE PATIENT WAS OUT OF DANGER. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15146841 ↗