ROI-C MC1312PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663016070), received between Oct 14, 2020 and Oct 19, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Crack; Crack

  IT WAS REPORTED THAT A SURGEON HAD MULTIPLE ROI-C CAGES THAT FRACTURED OR CRACKED INTRA-OPERATIVELY. TWO CAGES FRACTURED AT LEVEL C7/T1 AFTER INSERTING THE ANCHORING PLATES. THEY WERE EACH REMOVED AND REPLACED WITH A NEW CAGE. THE THIRD CAGE CRACKED AND THE SURGEON ELECTED TO LEAVE IT IN PLACE. THE SURGEON PROCEEDED TO THE C6/7 LEVEL AND INSTALLED THE FIRST CAGE, BUT IT WAS FOUND TO HAVE FRACTURED AFTER THE FIRST ANCHORING PLATE WAS INSTALLED. THE CAGE WAS AGAIN REMOVED AND REPLACED WITH A NEW CAGE AND THE SURGEON ELECTED NOT TO INSTALL THE ANCHORING PLATES AT THAT LEVEL. THERE WAS A DELAY OF THREE HOURS TO THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967569 ↗
• MalfunctionJan 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CONSTRUCT WAS INSTALLED TOO DEEP, THEN THE PLATES AND CAGE WERE DAMAGED WHEN BEING BACKED OUT OF THE DISC SPACE. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333711 ↗
• MalfunctionDec 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT A CAGE BROKE INTRA-OPERATIVELY WHILE THE MATING PLATE WAS BEING REMOVED BECAUSE THE PLATE WOULD NOT SEAT INTO THE CAGE. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH A COMPETITIVE CONSTRUCT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. DEVICE EVALUATION BY THE MANUFACTURER FOUND THE PLATE HAD ALSO FRACTURED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022006 ↗
• MalfunctionJul 21, 2021Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT WHILE INSERTING A PLATE THROUGH THE CAGE, THE PLATE BECAME STUCK AND COULD NOT BE ADVANCED OR REMOVED. THE CAGE WAS BROKEN TO REMOVE THE PLATE. THE CAGE WAS ALSO REMOVED AND BOTH PIECES WERE REPLACED WITH COMPETITIVE PRODUCT 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 12203139 ↗
• MalfunctionOct 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CAGE AND ANCHORING PLATE BROKE. THEY WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678228 ↗