Intervertebral Body Fusion Device 10-C3215-13Recalls & reported problems
Precision Spine, Inc. · Vault ALIF Peek Cage 32mm x 13mm 15 deg Lordosis · Class 2 · Implant
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 00840019908320), received between May 10, 2021 and May 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Mechanical Problem1
- Unstable1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2021Mechanical Problem; Unstable; Detachment of Device or Device Component
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN EQUADOR, UTILIZING THE VAULT ALIF SYSTEM. DURING THE PROCEDURE TWO (2) OF THE VAULT ALIF PLATES DID NOT ENGAGE ONTO THE CAGE. ALSO, ONE (1) CAGE AND PLATE BECAME UNSTABLE BECAUSE THE CONNECTOR SCREW CAME OFF. THE DOCTOR WAS ABLE TO COMPLETE THE CASE USING OTHER VAULT ALIF CAGES FROM THE SET. THERE WAS NO PATIENT INJURY REPORTED BUT THERE WAS A FORTY-FIVE (45) MINUTE DELAY OF THE PROCEDURE BECAUSE OF THE REPORTED ISSUES.
Patient problems: Insufficient Information
MAUDE report 11801748 ↗
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.
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