FORTIFY 151.052Recalls & reported problems
Globus Medical, Inc. · FORTIFY 12mm Core, Height 21-29mm · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095042900), received between Aug 30, 2022 and Mar 5, 2024 — classified as 4 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Output Problem1
- Product Quality Problem1
Patient problems
- Insufficient Information3
- Failure of Implant1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FORTIFY Ø12MM CORE THAT LOST HEIGHT POST-OPERATIVELY . THIS EVENT OCCURRED IN GERMANY.
Patient problems: Insufficient Information
MAUDE report 18837671 ↗MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FORTIFY INFERIOR ENDPLATE OF THE CAGE DISLODGED FROM THE CORE POST-OPERATIVELY REQUIRING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 18809734 ↗MalfunctionJan 18, 2023Material Integrity Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE A FORTIFY CORE THAT HAD LOST HEIGHT POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 16197040 ↗MalfunctionAug 30, 2022Output Problem
IT WAS REPORTED THAT A FORTIFY CORE HAS LOST HEIGHT 3 MONTHS POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 15320274 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.