ALEUTIAN® Interbody Systems 3303-90384Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857078895), received between Feb 14, 2022 and Mar 4, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506734 ↗
• MalfunctionApr 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ALEUTIAN TLIF ADJUSTABLE INSERTER AND INNER SHAFT WOULD NOT HOLD THE CASCADIA TL CAGE DURING INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE AND A 45 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053915 ↗
• MalfunctionFeb 14, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING CAGE PLACEMENT TWO ALEUTIAN TORQUE LIMITING SHAFTS AND ADJUSTABLE INSERTERS DISENGAGED FROM THE IMPLANT CAUSING INCORRECT PLACEMENT OF THE IMPLANT. THE INNER SHAFT WAS THEN REINSERTED TO REPOSITION THE CAGE, HOWEVER, NOW THE SURGEON COULD NO LONGER RELEASE THE CAGE FROM THE INSERTER. THIS RECORD CAPTURES THE SECOND TORQUE LIMITING INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529365 ↗
• MalfunctionFeb 14, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING CAGE PLACEMENT TWO ALEUTIAN TORQUE LIMITING SHAFTS AND ADJUSTABLE INSERTERS DISENGAGED FROM THE IMPLANT CAUSING INCORRECT PLACEMENT OF THE IMPLANT. THE INNER SHAFT WAS THEN REINSERTED TO REPOSITION THE CAGE, HOWEVER, NOW THE SURGEON COULD NO LONGER RELEASE THE CAGE FROM THE INSERTER. THIS RECORD CAPTURES THE FIRST TORQUE LIMITING INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529347 ↗