ALEUTIAN® Interbody Systems 3303-90151Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857076600), received between Apr 29, 2022 and Apr 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Device Reprocessing Problem; Contamination

  IT WAS REPORTED THAT AN ALEUTIAN TLIF II STRAIGHT INSERTER WAS OBSERVED TO CONTAIN FOREIGN RESIDUE INTRA-OPERATIVELY. THE DEVICE WAS THEN RE-STERILIZED AND CLEANED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 60 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836057 ↗
• MalfunctionMay 21, 2022No Apparent Adverse Event; Failure to Eject; No Apparent Adverse Event; Failure to Eject

  IT WAS REPORTED THAT AN ALEUTIAN TLIF II STRAIGHT INSERTER AND INNER SHAFT WERE UNABLE TO BE REMOVED FROM AN IMPLANT INTRA-OPERATIVELY. THE TIP OF THE INSERTER INNER SHAFT SUBSEQUENTLY FRACTURED OFF INSIDE THE IMPLANT. THE IMPLANT AND FRACTURED INNER SHAFT TIP WERE LEFT INSIDE THE PATIENT. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465752 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN TLIF II INSERTER HANDLE AND INNER SHAFT WAS BENT OUTSIDE THE OPERATING ROOM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255024 ↗