Intervertebral Body Fusion Device 10-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019908696), 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

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 32 MM X 13 MM 8 DEG LORDOSIS (B)(4) APPEARED TO BE SKEWED FROM THE VAULT ALIF PEEK CAGE 32 MM X 13 MM 8 DEG LORDOSIS (B)(4). 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 15476189 ↗