Irix-C Cervical Integrated Fusion System T066-0213Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697T06602131), received between May 3, 2021 and Feb 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionFeb 23, 2024Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/24/2024. IT WAS REPORTED THAT THE INTERNAL SHAFT OF A SYSTEM SCREW REMOVAL TOOL MALFUNCTIONED DURING A SURGICAL PROCEDURE. THE COMPLAINT SOURCE STATED, "WHEN THE SURGEON WAS TRYING TO BACK OUT A SCREW THAT WAS TOO LONG, THE TOP HALF OF THE INNER SHAFT SNAPPED OFF." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLIANT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 1/25/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768792 ↗
• MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 FOR AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THE COMPLAINANT REPORTED THAT WHILE A SURGEON WAS REMOVING A SYSTEM SCREW, THE DISTAL TIP OF A SCREW REMOVAL INSTRUMENT FRACTURED. THERE WERE NO DEFICIENCIES IDENTIFIED WITH THE SYSTEM IMPLANT OR SCREW. THE SCREW WAS REMOVED BECAUSE THE NEUROMONITORING MACHINE IDENTIFIED A LOSS IN MEP SIGNALS AND THE SURGEON WANTED TO CONFIRM THAT THERE WAS NO OBSTRUCTION TO THE SPINAL CORD. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760706 ↗