ROI-C MC1433PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663016483), received between Oct 13, 2020 and Nov 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionNov 19, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN ACDF SURGERY AFTER THE CERVICAL CAGE WAS INSERTED, A CRACK WAS NOTED IN THE UPPER PORTION OF THE IMPLANT. FOLLOWING SURGICAL GUIDE THE SURGEON DRILLED OFF AREAS FOR REMOVAL. THE IMPLANT WAS EFFECTIVELY DESTROYED DURING REMOVAL AND THE PIECES WERE RETRIEVED AND DISCARDED. A NEW IMPLANT OF THE SAME SIZE WAS THEN PLACED WITH ONLY A 20 MINUTE DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729614 ↗
• MalfunctionOct 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE C7/T1 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT THE SECOND PLATE. THE CAGE WAS FOUND TO BE FRACTURED, THE PLATE AND CAGE WERE REMOVED AND REPLACED WITH ALTERNATES OF THE SAME SIZE. AT THE C6/C7 LEVEL THE FIRST ANCHORING PLATE WAS HINDERED BY THE SUPERIOR ENDPLATE OF C7 AND WHEN THE SURGEON IMPACTED TO INSERT THE PLATE AND CAGE BROKE. AT THE C6 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT AND BOTH THE CAGE AND ANCHORING PLATE BROKE. THEY WERE REMOVED AND REPLACED WITH ALTERNATES. THE SURGEON OPTED TO NOT USE ANCHORING PLATES AT C6 AND C7 LEVELS. THERE WERE NO REPORTED PATIENT IMPACTS.THIS IS REPORT ONE OF SIX FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674747 ↗