CREO 5119.1982Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 9.5 x 80mm Polyaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889095106077), received between Dec 14, 2022 and Mar 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A CREO SCREW HEAD DISASSOCIATED FROM THE SCREW SHANK POST-OPERATIVELY, REQUIRING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 18830244 ↗MalfunctionDec 14, 2022Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVISION SURGERY THE SCREW HEAD OF A CREO THREADED POLYAXIAL SCREW POPPED OFF WHILE IT WAS BEING REMOVED. IT WAS LEFT IN THE PATIENT'S BODY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Foreign Body In Patient
MAUDE report 15978221 ↗
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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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