Intervertebral Body Fusion Device 10-P3208-13PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840019908474), received between May 10, 2021 and Sep 24, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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

Recent adverse event reports

The 3 most recent of 3 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 15475637 ↗
• InjuryMay 10, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN (B)(6), 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801865 ↗
• InjuryMay 10, 2021Activation, Positioning or Separation Problem; 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801838 ↗