ALEUTIAN® Interbody Systems 602-90449Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857117556), received between Mar 14, 2022 and Jan 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJan 27, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT AN ALEUTIAN AN INSERTER AND AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY AND THAT A DEVICE COMPONENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN AN MI INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189801 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INSERTION OF A CASCADIA OBLIQUE INTERBODY AS THE SURGEON ATTEMPTED TO ROTATE THE CAGE, THE TIP OF A CASCADIA LORDOTIC - OBLIQUE INSERTER AND A THREAD FROM THE TIP OF AN ALEUTIAN INSERTER INNER SHAFT FRACTURED INTRA-OPERATIVELY. THE BROKEN PIECES WERE RETRIEVED AND X-RAYS CONFIRMED THAT THERE WERE NO ARTIFACTS LEFT IN PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR THE ALEUTIAN INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352161 ↗
• MalfunctionMar 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE KNOBS OF TWO ALEUTIAN AN MI INSERTER INNER SHAFTS FELL OFF AFTER BEING STRUCK WITH A HAMMER INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF 2 SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760671 ↗
• MalfunctionMar 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE KNOBS OF TWO ALEUTIAN AN MI INSERTER INNER SHAFTS FELL OFF AFTER BEING STRUCK WITH A HAMMER INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FIRST OF 2 SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760505 ↗