Irix-A Lumbar Integrated Fusion System T080-0100-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697T080010041), received between Oct 25, 2019 and Dec 6, 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 6, 2022Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/08/2022. IT WAS REPORTED THAT A SYSTEM RONGEUR WAS BENT DURING A SURGICAL PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE 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 11/18/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929069 ↗
• MalfunctionOct 25, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE UPPER ARTICULATING ARM OF A PITUITARY RONGEUR CAME OFF DURING A PROCEDURE. THE PIECE WAS RETRIEVED WITH NO COMPLICATIONS OR DELAY IN TREATMENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242297 ↗