Irix-A Lumbar Integrated Fusion System T080-0100-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697T0800100101), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 10, 2026Improper or Incorrect Procedure or Method

  THE MANUFACTURER RECEIVED A COMPLAINT FROM A DISTRIBUTOR ON (B)(6) 2026 REPORTING THAT A 6 MM ANTERIOR KERRISON RONGEUR REPORTEDLY DISENGAGED DURING USE. THE COMPLAINANT INDICATED THE INSTRUMENT WAS BEING USED TO LEVERAGE OPEN THE DISC SPACE, AND DURING ROTATION, THE INSTRUMENT REPORTEDLY DISENGAGED. THE EVENT WAS REPORTED TO HAVE OCCURRED MORE THAN SIX MONTHS PRIOR TO NOTIFICATION; THEREFORE, SPECIFIC DETAILS REGARDING THE TIMING AND CIRCUMSTANCES OF THE EVENT ARE LIMITED. NO PATIENT INJURY, ADVERSE EVENT, OR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED. THE MANUFACTURER ISSUED AN RMA FOR RETURN OF THE COMPLAINT DEVICE; HOWEVER, AS OF (B)(6) 2026, THE DEVICE HAS NOT BEEN RETURNED AND EVALUATION COULD NOT BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458035 ↗