ROI-C MC1423PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663016421), received between Oct 28, 2020 and Jul 27, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 27, 2021Fracture; Fracture

  REPORTED THAT ONCE THE IMPLANT WAS FULLY INSERTED, THE TOP HALF FRACTURED OFF AFTER INSERTING THE SECOND PLATE. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT WITH A NEW IMPLANT & PLATES TO COMPLETE THE CASE WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229321 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SURGERY WHERE TWO ROI-C CONSTRUCTS WERE IMPLANTED, THE PATIENT SUFFERED FROM NEUROLOGICAL DEFICITS BUT WAS NOT PARALYZED. A REVISION SURGERY WAS PERFORMED THE NEXT DAY TO REMOVE ONE OF THE CONSTRUCTS AND REPLACE IT WITH A NARROWER SIZE OF THE SAME TYPE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10750746 ↗