ROI-C MC1313PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663016087), received between Oct 19, 2023 and Oct 19, 2023 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Fracture; Fracture

  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 THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967553 ↗
• MalfunctionOct 19, 2023Fracture; Fracture

  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 TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967538 ↗
• MalfunctionOct 19, 2023Fracture; Fracture

  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 ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967537 ↗