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ALEUTIAN® Interbody Systems 3203-21055SLRecalls & reported problems

VB Spine LLC · Lordotic 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857066601), received between Nov 24, 2015 and Nov 24, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryNov 24, 2015Migration or Expulsion of Device

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A LATERAL CAGE BACKED OUT AND REVISION WAS TO TAKE PLACE. THE CAGE BACKED OUT APPROXIMATELY 12 MONTHS POST-OP. REVISION SURGERY TOOK PLACE (B)(6) 2015.

    Patient problems: Pain

    MAUDE report 5245899 ↗

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Sources and updates

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