Irix-C Cervical Integrated Fusion System T066-0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M697T06600451), received between Sep 19, 2019 and Apr 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT A FORCEPS IMPLANT INSERTER WAS BROKEN WHEN IMPACTED WITH A MALLET FOR INSERTION OF A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/13/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677650 ↗
• MalfunctionNov 17, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON 10/24/2022 OF A SYSTEM IMPLANT INSERTER THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT A DISTAL ARM OF THE IMPLANT INSERTER FRACTURED WHILE PLACING A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGEON USED HOSPITAL INSTRUMENTATION TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/28/2022 FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819719 ↗
• MalfunctionApr 3, 2020Fracture; Fracture

  ON (B)(6) 2020 THE COMPANY RECEIVED A COMMUNICATION FROM A DISTRIBUTOR THAT A CRACK WAS IDENTIFIED ON AN INSTRUMENT. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2020 THE COMPLAINANT NOTICED THAT THE INSTRUMENT WAS NOT HOLDING THE IMPLANT WELL AND IDENTIFIED THE CRACK. IT IS UNKNOWN HOW THE CRACK PROPAGATED ON THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A GENERAL HOSPITAL INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9924463 ↗
• MalfunctionSep 19, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT DURING AN ACDF REVISION DUE TO NONUNION, A FORCEPS IMPLANT INSERTER AND A GUIDED ANGLED AWL WERE BROKEN. THE INITIAL SURGERY WAS REPORTEDLY A NON-X-SPINE PRODUCT. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THE INSTRUMENT MALFUNCTIONS. THE FOLLOWING MDRS CORRESPOND TO THIS EVENT: 3005031160-2019-00043.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088042 ↗