ALEUTIAN Interbody Systems 5303-90002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857110465), received between Feb 22, 2022 and Jun 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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.

• MalfunctionJun 22, 2022Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ALEUTIAN AN CORONAL INSERTER AND OUTER SHAFT/HANDLE WERE BROKEN AT THE BASE INTRA-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 14777589 ↗
• MalfunctionFeb 22, 2022Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED AN ALEUTIAN AN LORDOTIC OBLIQUE INSERTER BENT DURING IMPLANT ROTATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581307 ↗