CREO 5119.1645Recalls & reported problems
Globus Medical, Inc. · CREO® 5.5, 6.5 x 45mm Polyaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889095104141), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
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.
InjuryMar 4, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING FINAL TIGHTENING WITH THE TORQUE LIMITING DRIVER IN A SCREW ROD CONSTRUCT, THE LOCKING CAPS POPPED OUT AND THE SCREW HEAD WAS DAMAGED. THE SCREW HEAD WAS MONOAXIAL AT THIS STAGE AS EXPECTED. IN AN ATTEMPT TO REMOVE THE SCREW, THE SCREW HEAD NEEDED TO BECOME POLYAXIAL AGAIN. DURING THIS MANEUVER THE PEDICLE BROKE.
Patient problems: Spinal Column Injury
MAUDE report 18827940 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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