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ALEUTIAN® Interbody Systems 3303-21128MRecalls & reported problems

VB Spine LLC · TLIF II Implant · Class 2 · Implant

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 10888857073593), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionAug 17, 2022Material Deformation; Material Deformation

    A COMPANY REPRESENTATIVE REPORTED DEFORMATION OF THE ANTERIOR TEETH OF AN ALEUTIAN TLIF II IMPLANT. 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 15245547 ↗

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Sources and updates

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