Irix-A Lumbar Integrated Fusion System T080-0100-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697T080010071), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2022. IT WAS REPORTED THAT A SYSTEM BONE RONGEUR WAS IDENTIFIED AS BROKEN DURING A SURGICAL PROCEDURE. THE COMPLAINANT STATED THAT THE SURGEON USED THE BONE RONGEUR, PLACED IT ON THE MAYO STAND, AND THE NEXT TIME HE PICKED IT UP NOTICED A SCREW HAD COME OUT OF THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATIVE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997212 ↗