FORTIFY 137.001Recalls & reported problems
Globus Medical, Inc. · FORTIFY I 12mm Core, Height 23-28mm,12x14mm Footprint, 0°, No Spikes · Class 2 · Implant
All models of FORTIFY (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00889095040777), received between May 6, 2026 and May 6, 2026 — 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. 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
- Migration1
Patient problems
- 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.
MalfunctionMay 6, 2026Migration
IT WAS REPORTED THAT THE REASON FOR REVISION WAS THAT AFTER THE FIRST SURGERY (DURING A CONTROL CT SCAN), IT WAS FOUND THAT FORTIFY I CHANGED HEIGHT IN PATIENT'S BODY AND THE SCREWS HAD BECOME LOOSE. THE AIM OF THE REVISION WAS TO REMOVE FORTIFY I AND REPLACE IT WITH XPAND + EXTEND. I. THIS EVENT TOOK PLACE IN POLAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25102236 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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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