CREO 5119.1742Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 7.5 x 40mm Polyaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095104691), received between Mar 31, 2022 and Mar 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Material Protrusion/Extrusion1
- Product Quality Problem1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT DURING A REVISION SURGERY FOR RADICULOPATHY, CREO SCREWS WERE FOUND LOOSE AND REPLACED AT L2, L5. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834297 ↗MalfunctionAug 26, 2022Material Protrusion/Extrusion
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE A CREO THREADED SCREW THAT HAD FOUND TO BE PROJECTED THOUGH THE BONE POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 15300010 ↗MalfunctionMar 31, 2022Loose or Intermittent Connection
IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO (2) CREO THREADED SCREWS THAT LOOSENED 11 MONTHS POST-OPERATIVELY. THIS EVENT WAS OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 13970801 ↗
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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