ALEUTIAN® Interbody Systems SP-3140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857421080), received between Aug 21, 2020 and Jun 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Mechanical Jam; Failure to Eject; Mechanical Jam; Failure to Eject

  IT WAS REPORTED THAT AN ALEUTIAN LATERAL SYSTEM ANGLED INSERTER WAS LOCKED INTO THE CAGE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT WILL CAPTURE THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639251 ↗
• MalfunctionOct 22, 2020Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT AN ALEUTIAN LATERAL SYSTEM ANGLED LATERAL INSERT TIP GOT STUCK IN THE CASCADIA LATERAL INTERBODY. THE SURGEON WAS UNABLE TO REMOVE THE INSERTER FROM THE IMPLANT AFTER MULTIPLE ATTEMPTS. THE SURGEON HAD TO SNAP THE TIP OFF OF THE INSERTER AND LEAVE IT IN THE INNER THREADS OF THE CASCADIA LATERAL INTERBODY, WHICH REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A STRAIGHT INSERTER FOR THE SECOND INTERBODY, FOLLOWED UP WITH SCREWS. THIS EVENT RESULTED IN A 30 MINUTE SURGICAL DELAY AND WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10717833 ↗
• MalfunctionAug 21, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN ALEUTIAN LATERAL INSERTER WOULD NOT DISENGAGE FROM AN IMPLANT DURING INTRA-OPERATIVE CAGE PLACEMENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE INSERTER WITH A 30 MINUTE SURGICAL DELAY. THIS REPORT CAPTURES THE INSERTER.

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

  MAUDE report 10438688 ↗