FORTIFY 151.050Recalls & reported problems
Globus Medical, Inc. · FORTIFY 12mm Core, Height 18-23mm · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095042887), received between Dec 14, 2021 and Dec 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Collapse” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse2
- Output Problem1
Patient problems
- Insufficient Information2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Collapse; Collapse
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE A FORTIFY Ø12MM CORE DUE TO HEIGHT LOSS AND PATIENT PAIN POST OPERATIVELY.
Patient problems: Pain
MAUDE report 20879169 ↗MalfunctionOct 9, 2024Collapse; Collapse
IT WAS REPORTED THAT A REVISION FOR A FORTIFY SPACER THAT LOST HEIGHT POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20410567 ↗MalfunctionDec 14, 2021Output Problem
IT WAS REPORTED THAT A FORTIFY IMPLANT HAS LOST HEIGHT POST OPERATIVELY. THIS EVENT OCCURRED IN THE UK.
Patient problems: Insufficient Information
MAUDE report 13004280 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.