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FORTIFY 151.151Recalls & reported problems

Globus Medical, Inc. · FORTIFY 20mm Core, Height 26-34mm · 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 00889095043037), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 16, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED BY A REPRESENTATIVE FROM GERMANY THAT A REVISION SURGERY WAS COMPLETED DUE TO A FORTIFY IMPLANT AND SCREWS WHICH DISLOCATED POST-OPERATIVELY.

    Patient problems: Insufficient Information

    MAUDE report 12181111 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.