FORTIFYRecalls & reported problems across all models
Globus Medical, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 14 models of FORTIFY by Globus Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2020 and Jun 17, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Collapse” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FORTIFY problems
Device problems
- Collapse15
- Insufficient Device Problem Information4
- Output Problem3
- Appropriate Device Problem Term/Code Not Available2
- Migration2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Human-Device Interface Problem1
Patient problems
- Insufficient Information19
- Failure of Implant5
- No Clinical Signs, Symptoms or Conditions5
- Pain2
- Ambulation or Postural Difficulties1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Spinal Column Injury1
FORTIFY models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FORTIFY 151.053SPINAL VERTEBRAL BODY REPLACEMENT DEVICE8 reports
- FORTIFY 151.051SPINAL VERTEBRAL BODY REPLACEMENT DEVICE6 reports
- FORTIFY 151.052SPINAL VERTEBRAL BODY REPLACEMENT DEVICE4 reports
- FORTIFY 151.050SPINAL VERTEBRAL BODY REPLACEMENT DEVICE3 reports
- FORTIFY 151.152SPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- FORTIFY 137.001SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 137.300SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.002SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.003SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.151SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.153SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.154SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 351.051SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- FORTIFY 151.050SSpinal vertebral body replacement device1 report
Recent FORTIFY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Collapse
IT WAS REPORTED THAT ON (B)(6) 2026 THE SURGEON ANNOUNCED A NEW FORTIFY COLLAPSE INCIDENT IN CHUV (LUMBAR REGION). THIS INCIDENT WAS DETECTED AFTER A YEARLY POST-OPERATIVE CHECK. THE PATIENT WAS OPERATED ON (B)(6) 2023 AND IS CURRENTLY ASYMPTOMATIC.
Patient problems: Insufficient Information
MAUDE report 25531696 ↗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 ↗MalfunctionApr 21, 2026Collapse
IT WAS REPORTED THAT A FORTIFY CAGE WAS PLACED INTO PATIENT IN (B)(6) 2025. THEN ON (B)(6) 2026 PATIENT HEARD A "CLUNK" AND THE CAGE THAT WAS EXPANDED HAD COLLAPSED. THE PATIENT WAS TAKEN BACK INTO SURGERY AND A NEW FORTIFY CAGE WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940789 ↗InjuryApr 21, 2026Collapse
IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON FOR A CHORDOMA TUMOR ON (B)(6) 2024. THEN IN HIS FOLLOW UP APPOINTMENT ON (B)(6) 2026 IT WAS DETERMINED THE CAGE HAD COLLAPSED. IN REVIEW OF PRIOR APPOINTMENTS, IT'S BEEN DETERMINED THAT CAGE COLLAPSED WAS ALSO OCCURRING ON (B)(6) 2024. THE PATIENT WILL BE SCHEDULED FOR REVISION SOMETIME IN MAY.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 24940786 ↗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 ↗MalfunctionOct 3, 2025Collapse; Collapse
IT WAS REPORTED THAT A REVISION SURGERY OCCURRED TO REMOVE A FORTIFY CAGE THAT COLLAPSED.
Patient problems: Failure of Implant
MAUDE report 23213409 ↗MalfunctionSep 19, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT TWO FORTIFY IMPLANTS WERE UNABLE TO EXPAND AFTER ASSEMBLY AND THE SURGEON HAD TO ABORT THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23100891 ↗MalfunctionMar 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A FORTIFY SPACER HAS LOST HEIGHT POST-OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 21633811 ↗MalfunctionDec 9, 2024Collapse; Collapse
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE A FORTIFY Ø12MM CORE DUE TO HEIGHT LOSS AND PATIENT PAIN POST OPERATIVELY.
Patient problems: Pain
MAUDE report 20879169 ↗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 ↗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 ↗MalfunctionOct 9, 2024Collapse; Collapse
IT WAS REPORTED THAT A REVISION FOR A FORTIFY SPACER THAT LOST HEIGHT POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20410567 ↗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 ↗MalfunctionMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING A REVISION SURGERY IT WAS FOUND THAT A FORTIFY Ø20MM CORE HAD LOST HEIGHT 2 YEARS POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18837731 ↗
Other Globus Medical, Inc. products
All Globus Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page