ALEUTIAN Interbody Systems 5203-90101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857108158), received between Feb 2, 2021 and May 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE THREADS OF AN ALEUTIAN AN INSERTER BROKE OFF INSIDE THE ALEUTIAN AN CORONAL INSERTER OUTER SHAFT/HANDLE POST-OPERATIVELY. 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 14427925 ↗
• MalfunctionFeb 2, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT THE ALEUTIAN AN LORDOTIC INNER INSERTER BROKE AND WAS JAMMED INTO THE ALEUTIAN AN LORDOTIC OUTER T-HANDLE SHEATH INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266813 ↗