Irix-C Cervical Integrated Fusion System T066-0300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M697T06603001), received between Oct 18, 2022 and Oct 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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 26, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED AND BECAME AWARE OF TWO UNEXPECTED MALFUNCTIONED SYSTEM AWLS ON 10/04/2022. THERE WERE NO CURRENT COMMUNICATIONS OR OPEN COMPLAINT INVESTIGATIONS FOR THESE RETURNED INSTRUMENTS. EMAIL COMMUNICATIONS WERE MADE WITH THE COMPLAINANT, WHO STATED THAT THE RETURNED INSTRUMENTS HAD PREVIOUSLY BEEN ADDRESSED THROUGH THE COMPLAINT MANAGEMENT SYSTEM. THE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE INSTRUMENTS HAD BEEN PREVIOUSLY REPORTED BY THE COMPLAINANT. THE COMPLAINANT STATED THAT THE TWO SYSTEM AWLS BOTH MALFUNCTIONED DURING PROCEDURES AND CONFIRMED THAT NEITHER MALFUNCTION RESULTED IN ANY PATIENT COMPLICATIONS. NO OTHER INFORMATION ON THE SYSTEM AWL MALFUNCTIONS WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677732 ↗
• MalfunctionOct 26, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED AND BECAME AWARE OF TWO UNEXPECTED MALFUNCTIONED SYSTEM AWLS ON (B)(6) 2022. THERE WERE NO CURRENT COMMUNICATIONS OR OPEN COMPLAINT INVESTIGATIONS FOR THESE RETURNED INSTRUMENTS. EMAIL COMMUNICATIONS WERE MADE WITH THE COMPLAINANT, WHO STATED THAT THE RETURNED INSTRUMENTS HAD PREVIOUSLY BEEN ADDRESSED THROUGH THE COMPLAINT MANAGEMENT SYSTEM. THE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE INSTRUMENTS HAD BEEN PREVIOUSLY REPORTED BY THE COMPLAINANT. THE COMPLAINANT STATED THAT THE TWO SYSTEM AWLS BOTH MALFUNCTIONED DURING PROCEDURES AND CONFIRMED THAT NEITHER MALFUNCTION RESULTED IN ANY PATIENT COMPLICATIONS. NO OTHER INFORMATION ON THE SYSTEM AWL MALFUNCTIONS WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677731 ↗
• MalfunctionOct 18, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON 9/22/2022 OF A SYSTEM AWL THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. A REPLACEMENT INSTRUMENT WAS PROVIDED TO THE COMPLAINANT AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/04/2022 FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620973 ↗