ALEUTIAN Interbody Systems 5303-90004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857110489), received between May 18, 2022 and Jul 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• MalfunctionJul 6, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SET REASSEMBLY OUTSIDE THE OR, THE KNOB OF AN ALEUTIAN AN CORONAL INSERTER OUTER SHAFT/HANDLE AND INSERTER WAS JAMMED. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN. THIS REPORT CAPTURES OUTER SHAFT/HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14932701 ↗
• MalfunctionJun 22, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; 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 OUTER SHAFT/HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777590 ↗
• MalfunctionJun 14, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TIP OF AN ALEUTIAN AN CORONAL INSERTER WAS FRACTURED AND THE OUTER SHAFT/HANDLE WAS BROKEN OUTSIDE THE OR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691402 ↗
• MalfunctionMay 18, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  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 OUTER SHAFT/HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427865 ↗