ALEUTIAN® Interbody Systems 3201-90293Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857059313), received between May 3, 2021 and Dec 20, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionDec 20, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT TWO ALEUTIAN GRAFT CONTAINMENT RAMPS WERE BENT AND BROKEN INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD WILL CAPTURE THE SECOND OF TWO RAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047765 ↗
• MalfunctionDec 20, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT TWO ALEUTIAN GRAFT CONTAINMENT RAMPS WERE BENT AND BROKEN INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD WILL CAPTURE THE FIRST OF TWO RAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047712 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ALEUTIAN LATERAL GRAFT CONTAINMENT RAMP SHOWED SIGNS OF WEAR 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 11773586 ↗
• MalfunctionMay 3, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT AN ALEUTIAN LATERAL INSERTER INNER SHAFT WAS NOT THREADING PROPERLY ONTO THE IMPLANT AND AN ALEUTIAN LATERAL GRAFT CONTAINMENT RAMP SHOWED SIGNS OF WEAR INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE DELAY TO SURGERY BY USING THE COMPLAINT DEVICES. THIS REPORT CAPTURES THE GRAFT RAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761185 ↗