FORTIFY 151.002Recalls & reported problems
Globus Medical, Inc. · FORTIFY 12mm Core, Height 16-19mm, 0deg · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095042856), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Collapse” (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
- Collapse1
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Collapse; Collapse
IT WAS REPORTED THAT THE IMPLANT COLLAPSED WHILE IMPLANTED IN PATIENTS NECK. IT WAS RECOGNIZED ON POST OP SCAN. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND SENT FOR DECONTAMINATION.
Patient problems: Spinal Column Injury
MAUDE report 23542101 ↗
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- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.