FORTIFY 151.053Recalls & reported problems
Globus Medical, Inc. · FORTIFY 12mm Core, Height 25-37mm · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889095042917), received between May 5, 2021 and Mar 4, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Collapse” (3 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
- Collapse3
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Problem1
- Output Problem1
- Unintended System Motion1
Patient problems
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Fall1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A FORTIFY I SPACER COLLAPSED POST-OPERATIVELY REQUIRING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 18832871 ↗MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A FORTIFY CERVICAL CAGE COLLAPSED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18830227 ↗MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion
A FORTIFY CAGE LOST HEIGHT POST-OPERATIVELY. A REVISION SURGERY HAS NOT BEEN PERFORMED.
Patient problems: Failure of Implant
MAUDE report 18825546 ↗MalfunctionMar 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A FORTIFY SPACER LOST HEIGHT POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18821417 ↗MalfunctionSep 14, 2021Output Problem
IT WAS REPORTED THAT A FORTIFY CAGE HAS LOST HEIGHT POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 12467561 ↗MalfunctionAug 31, 2021Collapse; Mechanical Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS COMPLETED TO REMOVE A FORTIFY CAGE THAT COLLAPSED POST OPERATIVELY.
Patient problems: Fall
MAUDE report 12395517 ↗MalfunctionJun 16, 2021Collapse
IT WAS REPORTED BY A REPRESENTATIVE FROM THE UK THAT A REVISION SURGERY WAS DONE FOR A FORTIFY CAGE THAT COLLAPSED POST-OPERATIVELY, CAUSING ADVERSE EFFECTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12012652 ↗MalfunctionMay 5, 2021Collapse; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE DUE TO A FORTIFY 12MM CORE COLLAPSING POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 11778769 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.