ALEUTIAN® Interbody Systems 602-90448Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857117549), received between Apr 22, 2025 and Jan 27, 2026 — classified as 2 malfunctions.

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

• MalfunctionJan 27, 2026Fracture; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN AN INSERTER AND AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT A DEVICE COMPONENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN AN MI INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189795 ↗
• MalfunctionApr 22, 2025Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN AN INSERTER FRACTURED, THE TIP OF AN ALEUTIAN AN INSERTER DEFORMED, AND THE TIP OF AN ALEUTIAN AN MI INSERTER DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 90 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE DEFORMED ALEUTIAN AN MI INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887095 ↗