FORTIFY 151.051Recalls & reported problems
Globus Medical, Inc. · FORTIFY 12mm Core, Height 19-25mm · Class 2 · Implant
All models of FORTIFY (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889095042894), received between Sep 11, 2020 and Oct 23, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Collapse” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse5
- Unintended Movement1
Patient problems
- Insufficient Information3
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2024Collapse; Collapse
IT WAS REPORTED THAT REVISION WAS NEEDED TO REPLACE A FORTIFY SPACER THAT LOST HEIGHT POST-OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 20517125 ↗MalfunctionAug 22, 2024Collapse; Collapse
IT WAS REPORTED THAT A FORTIFY SPACER HAS LOST HEIGHT POST-OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 20031313 ↗MalfunctionJun 21, 2024Collapse; Collapse
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE FORTIFY CORE THAT LOST HEIGHT POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRALIA.
Patient problems: Insufficient Information
MAUDE report 19584430 ↗MalfunctionNov 22, 2022Collapse
IT WAS REPORTED THERE WAS A REVISION SURGERY TO REPLACE A FORTIFY SPACER THAT HAD COLLAPSED POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 15844918 ↗MalfunctionOct 28, 2022Collapse
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A FORTIFY CORE THAT COLLAPSED 4 MONTHS POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 15692665 ↗MalfunctionSep 11, 2020Unintended Movement
IT WAS REPORTED THAT A FORTIFY TITANIUM CAGE LOST HEIGHT POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10524643 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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