SAHARA™ Stabilization System 5808-21230L5Recalls & reported problems
VB Spine LLC · Expandable ALIF Size 24x30x12 mm, 5 Deg. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857213197), received between Jun 9, 2017 and Jun 9, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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
Device problems
- Migration or Expulsion of Device2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON 05.12.2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE EXPANDABLE ALIF CAGE COLLAPSE. THE PATIENT REPORTEDLY HAD A POSSIBLE CAGE COLLAPSE APPROXIMATELY LESS THAN 1 MONTH POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME.
Patient problems: No Information
MAUDE report 6632461 ↗MalfunctionJun 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE EXPANDABLE ALIF CAGE COLLAPSE. THE PATIENT REPORTEDLY HAD A POSSIBLE CAGE COLLAPSE APPROXIMATELY LESS THAN 1 MONTH POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME.
Patient problems: No Information
MAUDE report 6632452 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page