CREO 5119.6645Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 6.5 x 45mm Reduction Screw · Class 2
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095120592), received between Sep 29, 2020 and Mar 1, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, 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
- Detachment of Device or Device Component2
- Human-Device Interface Problem1
- Material Separation1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Spinal Column Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE RIGHT L1 SCREW HEAD DISASSOCIATED FROM THE SCREW APPROXIMATELY TWO DAYS POST-OPERATIVELY. ADDITIONALLY, IT WAS FOUND DURING THE REVISION THAT THE LEFT L1 SCREW HAD PULLED OUT OF THE PEDICLE.
Patient problems: Insufficient Information
MAUDE report 18816833 ↗MalfunctionJan 16, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE CREO SCREWS THAT WERE FOUND BROKEN POST OPERATIVELY. THIS EVENT OCCURRED IN IRELAND.
Patient problems: Spinal Column Injury
MAUDE report 18517644 ↗MalfunctionOct 22, 2021Detachment of Device or Device Component
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE A DISSOCIATED SCREW HEAD AT RIGHT L1 SIX DAYS AFTER THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).
Patient problems: Insufficient Information
MAUDE report 12683119 ↗MalfunctionSep 29, 2020Detachment of Device or Device Component
IT WAS REPORTED THAT SCREW HEAD DISSOCIATED FROM THE SCREW INTRA-OPERATIVELY. THE SCREW WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10603144 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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