Irix-A Lumbar Integrated Fusion System X080-5525SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697X0805525SD1), received between Jan 11, 2023 and Mar 2, 2023 — classified as 2 malfunctions.

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

• MalfunctionMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/02/2023. IT WAS REPORTED THAT SYSTEM IMPLANT SCREWS WERE IDENTIFIED AS HAVING BACKED OUT POST-OPERATIVELY. THE HEALTH STATUS OF THE PATIENT WAS REPORTED AS GOOD, AND THAT A REVISION PROCEDURE WOULD BE PERFORMED. REQUESTS FOR AVAILABLE SURGICAL AND POST-OPERATIVE IMAGES WERE MADE, ALTHOUGH THERE WERE NONE AVAILABLE FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469752 ↗
• MalfunctionJan 11, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2022. IT WAS REPORTED THAT A SYSTEM IMPLANT SCREW WAS IDENTIFIED AS HAVING BACKED OUT POST-OPERATIVELY. NO OTHER INFORMATION WAS INITIALLY AVAILABLE, AND REQUESTS FOR RELEVANT COMPLAINT INCIDENT INFORMATION WERE MADE ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141950 ↗