ALEUTIAN® Interbody Systems 602-90780Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888857157255), received between Jun 30, 2020 and Sep 23, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fracture; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874005 ↗
• MalfunctionJun 9, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448052 ↗
• MalfunctionAug 11, 2025Material Deformation; 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 INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777811 ↗
• MalfunctionApr 10, 2025Material Deformation; 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 INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822428 ↗
• MalfunctionMar 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE LATERAL PRONGS OF TWO CASCADIA LORDOTIC OBLIQUE INSERTERS AND THE THREADING OF AN ALEUTIAN INSERTER INNER SHAFT FRACTURED DURING CAGE INSERTION. THE SURGEON THEN SWITCHED FROM AN OBLIQUE TLIF CAGE TO A PLIF CAGE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610220 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT THREADING FROM AN ALEUTIAN INSERTER'S INNER SHAFT FRACTURED INTRA-OPERATIVELY DURING CAGE INSERTION. THE THREADING WAS LEFT IN THE IMPLANTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916877 ↗
• MalfunctionSep 5, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT THE KNOB OF AN ALEUTIAN INSERTER'S INNER SHAFT FRACTURED INTRA-OPERATIVELY DURING CAGE INSERTION, THE ALEUTIAN INSERTER JAMMED WITH THE CAGE AND THE SURGEON "HAD TO CUT" THE INSERTER SHAFT TO DETACH IT FROM THE INSERTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE ALEUTIAN INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687541 ↗
• MalfunctionAug 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ALEUTIAN AN INSERTER'S INNER SHAFT SCREW CAP BROKE OFF DURING CAGE INSERTION INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196050 ↗
• MalfunctionJul 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING IMPLANT IMPACTION, THE TOP OF THE ALEUTIAN AN INSERTER INNER SHAFT BROKE OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 SECOND SURGICAL DELAY BY USING AN ALTERNATIVELY AVAILABLE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126575 ↗
• MalfunctionMay 21, 2022Fracture; Fracture

  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 INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465737 ↗
• MalfunctionApr 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE KNOB OF AN ALEUTIAN AN INSERTER FRACTURED OFF FROM THE SHAFT INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979860 ↗
• MalfunctionJan 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN INSERTER AND ALEUTIAN AN INNER SHAFT BROKE AT THE TIP INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170562 ↗
• MalfunctionDec 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN AN INSERTER INNER SHAFT FRACTURED DURING CAGE ROTATION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908932 ↗
• MalfunctionJun 30, 2020Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT AN ALEUTIAN TLIF II STRAIGHT INSERTER INNER SHAFT WAS JAMMED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10213655 ↗