Intervertebral Body Fusion Device 10-C3208-13Recalls & reported problems
Precision Spine, Inc. · Vault ALIF Peek Cage 32mm x 13mm 8 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 00840019908276), received between Sep 24, 2022 and Sep 24, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Problem” (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
- Positioning Problem1
- Use of Device Problem1
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.
InjurySep 24, 2022Use of Device Problem; Positioning Problem
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE VAULT ALIF SYSTEM. THE PLATE AND CAGE WERE ASSEMBLED ON THE BACK TABLE. THE SET SCREW WAS TORQUED TO ASSEMBLE THE PLATE AND CAGE COMPONENTS . THE ASSEMBLY WAS THEN INSERTED INTO THE DISC SPACE WITH FOUR SCREWS. UPON ATTEMPTING TO ASSEMBLE THE LOCK SCREW IT WAS NOTED THAT IT DID NOT SEEM TO FIT AS USUAL. AN X-RAY WAS THEN TAKEN AND IT WAS NOTED THE VAULT ALIF PEEK PLATE 32MM X 13MM 8 DEG LORDOSIS (10-P3208-13P) APPEARED TO BE SKEWED FROM THE VAULT ALIF PEEK CAGE 32MM X 13MM 8 DEG LORDOSIS (10-C3208-13). THE SCREWS AND PLATE/CAGE ASSEMBLY WERE REMOVED AND REPLACED WITH OTHERS OF THE SAME SIZE WITH NO FURTHER ISSUE.
Patient problems: Insufficient Information
MAUDE report 15476647 ↗
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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