ROI-C MC1442PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663016537), received between Jul 15, 2019 and Dec 3, 2025 — classified as 2 injuries, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY TO EXTEND A CONSTRUCT, WHILE PUTTING THE ANCHORING PLATE IN, AN ROI-C IMPLANT BROKE WHERE IT CONNECTS TO THE INSERTER. THE SURGERY WAS COMPLETED WITH ANOTHER ROI-C IMPLANT WITHOUT ANY PATIENT OR PROCEDURAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707083 ↗
• MalfunctionMay 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE FRACTURED IN THE C2/3 DISC SPACE INTRA-OPERATIVELY WHILE INSTALLING THE SECOND PLATE. THE CAGE AND PLATES WERE REMOVED AND REPLACED WITH A NEW CAGE AND PLATES. THE FRACTURED PIECES OF THE CAGE WERE RECOVERED. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903809 ↗
• MalfunctionMar 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE ANCHORING PLATE WOULD NOT ADVANCE THROUGH THE PATIENT'S BONE AT C4 OF A C4/5 ROI-C CONSTRUCT INTRAOPERATIVELY. WHILE REMOVING THE PLATE, THE CAGE CRACKED. BOTH COMPONENTS WERE REMOVED AND REPLACED WITH NEW ONES TO COMPLETE THE PROCEDURE. THE SURGEON SAID THE PATIENT HAD HARD, SCLEROTIC BONE SO HE USED THE AWL AT THAT LEVEL PRIOR TO RE-INSTALLING THE PLATES. THERE WERE NO PATIENT IMPACTS, BUT THERE WAS A DELAY OF 20 MINUTES TO REMOVE AND THE CAGE AND PLATE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658497 ↗
• InjuryJul 15, 2019Break; Break

  ROI-C: 3 BROKEN CAGES AND BENT AWL. ACCORDING TO THE AVAILABLE DESCRIPTION , THE SURGEON WAS IMPACTING ANCHORING PLATE WITH IMPACTOR 1 THEN 2 AT C5-6 WHEN PEEK CAGE CRACKED (12X14 H6). HE REMOVED THE ANCHORING PLATES AND PEEK DEBRIS. HE PROCEEDED TO TRY IT AGAIN WITH A NEW PEEK CAGE AND PLATES (12 X14 H6) AND AGAIN THE PEEK CRACKED JUST LIKE BEFORE. HE REMOVED THE ANCHORING PLATES AND PEEK DEBRIS. THE REPORTER SUGGESTED THE AWL AND USING A NEW INSERTER AND HE AGREED TO DO BOTH. AFTER USING THE AWL AND NEW INSERTER HE IMPLANTED THE NEW PEEK AND PLATE (12X14 H6) CRACKED AGAIN FOLLOWING IMPACTOR 1 & 2. THE AWL WAS ALSO BENT AT THE TIP AFTER IMPACTING. SURGERY DELAYED 1 HOUR. NO PATIENT IMPACT OR SERIOUS INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. INVESTIGATION ONGOING.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8788791 ↗
• InjuryJul 15, 2019Break; Break

  IT WAS REPORTED THAT 3 CAGES BROKE WHILE IMPACTING THE ANCHORING PLATE. THE SURGERY WAS DELAYED OVER 30 MINUTES TO REMOVE AND REPLACE THE DEVICES. THIS IS REPORT 1 OF 3.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8788745 ↗