FORTIFY 351.051Recalls & reported problems
Globus Medical, Inc. · FORTIFY-R 14mm Core, Height 28-40mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095217285), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2024Migration; Migration
IT WAS REPORTED THAT REVISION WAS NEEDED TO REPLACE A FORTIFY SPACER THAT DEVIATED POST-OPERATIVELY. THIS EVENT OCCURRED IN SWEDEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20516236 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.