ALEUTIAN® Interbody Systems 3303-90603Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888857157668), received between Apr 27, 2021 and Jul 14, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820822 ↗
• MalfunctionMar 3, 2026Fracture; Material Deformation; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN TLIF II ADJUSTABLE INSERTER WAS DIFFICULT TO DISASSEMBLE FROM A CAGE AND THAT AN ALEUTIAN TLIF II ADJUSTABLE INSERTER INNER SHAFT WAS "BROKEN" INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503623 ↗
• MalfunctionMar 7, 2025Material Deformation; Material Deformation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548590 ↗
• MalfunctionJul 6, 2022Fracture; Ejection Problem; Fracture; Ejection Problem

  IT WAS REPORTED THAT THE PIN ON THE BAYONET ATTACHMENT OF AN ALEUTIAN TLIF II INSERTER RELEASED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14933927 ↗
• MalfunctionMay 5, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN ALEUTIAN TLIF II INSERTER WOULD NOT RELEASE THE CAGE DURING INCOMING INSPECTION. THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES WERE SEEN TO ANY PATIENTS. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289275 ↗
• 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 INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053905 ↗
• MalfunctionFeb 14, 2022Mechanical Jam; 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 INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529399 ↗
• MalfunctionFeb 14, 2022Mechanical Jam; 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 INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529376 ↗
• MalfunctionDec 30, 2021Fracture; Material Deformation; Fracture; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II INSERTER FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119595 ↗
• MalfunctionJun 23, 2021Fracture; Material Deformation; Mechanical Jam; Fracture; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE ALEUTIAN TLIF II INSERTER BECAME STUCK DURING INSERTION AND BROKE AT THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050192 ↗
• MalfunctionApr 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN TLIF ADJUSTABLE INSERTER WAS JAMMING DURING INTRA-OPERATIVE IMPLANT INSERTION. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734583 ↗