Irix-A Lumbar Integrated Fusion System T080-0042Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697T08000421), received between Jan 18, 2019 and Dec 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionDec 14, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON 11/15/2022. IT WAS REPORTED THAT A SYSTEM IMPLANT INSERTER MALFUNCTIONED DURING A SURGICAL PROCEDURE AFTER BEING IMPACTED FOR IMPLANT PLACEMENT AND WAS REQUESTED TO BE REPLACED. THE FRACTURED PORTION OF THE IMPLANT INSERTER WAS RECOVERED AND THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATIVE AVAILABLE IMPLANT INSERTER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 11/17/2022 FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978367 ↗
• MalfunctionJan 18, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT AN IRIX-A INSERTER BROKE, THE BREAKAGE WAS NOTICED FOLLOWING A CASE, THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262905 ↗