ALEUTIAN® Interbody Systems 602-90776Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857120471), received between May 21, 2022 and Oct 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO ALEUTIAN AN INSERTERS FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330820 ↗
• MalfunctionOct 17, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO ALEUTIAN AN INSERTERS FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330755 ↗
• MalfunctionAug 11, 2025Fracture; Material Deformation; Fracture; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777807 ↗
• MalfunctionApr 22, 2025Fracture; Material Deformation; Fracture; Material Deformation

  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 FRACTURED ALEUTIAN AN INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887093 ↗
• MalfunctionApr 22, 2025Fracture; Material Deformation; Fracture; Material Deformation

  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 INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887092 ↗
• MalfunctionApr 10, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF AN ALEUTIAN AN INSERTER AND AN ALEUTIAN AN INSERTER INNER SHAFT DEFORMED INTRA-OPERATIVELY DURING CAGE INSERTION, AND THAT THE CAGE ALSO DEFORMED. IT WAS FURTHER REPORTED THAT THE CAGE REMAINS IMPLANTED IN THE PATIENT. NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822439 ↗
• MalfunctionMay 21, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT THE KNOB OF AN ALEUTIAN AN INSERTER AND INNER SHAFT BROKE OFF DURING INTRA-OPERATIVE IMPLANT PLACEMENT. 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 14465735 ↗