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ALEUTIAN® Interbody Systems 602-90367Recalls & reported problems

VB Spine LLC · Convex Trial, Size 10x32x11 mm · Class 2

All models of ALEUTIAN Interbody Systems (37)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857116757), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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

Device problems

  • Naturally Worn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 16, 2021Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE LASER MARKINGS OF THE ALEUTIAN AN CONVEX TRIAL WERE OBSERVED TO BE WORN 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 13022254 ↗

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Sources and updates

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