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SAHARA™ Stabilization System 5808-21540L10Recalls & reported problems

VB Spine LLC · Expandable ALIF Size 30x40x15 mm, 10 Deg. · Class 2 · Implant

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 10888857213357), received between Dec 21, 2016 and Dec 21, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Collapse” (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

  • Collapse1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionDec 21, 2016Collapse; Collapse

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE EXPANDABLE ALIF COLLAPSE. THE PATIENT REPORTEDLY HAD AN EXPANDABLE ALIF COLLAPSE APPROXIMATELY 1 ½ MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME AS THE PATIENT IS ASYMPTOMATIC.

    Patient problems: No Information

    MAUDE report 6194770 ↗

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Sources and updates

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