CREO 1134.0110Recalls & reported problems
Globus Medical, Inc. · CREO MIS Modular Polyaxial Tulip, 10mm reduction · Class 2
All models of CREO (100)
Data updated Oct 18, 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 00889095071153), received between Apr 13, 2021 and Mar 5, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fracture1
- Human-Device Interface Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- Failure of Implant1
- 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 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A SURGERY WAS DELAYED BY 3 HOURS DUE TO ISSUES WITH A CREO SCREW HEAD POPPING OFF DURING REMOVAL. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834176 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT POST-OPERATIVE CT SCANS SHOWED A CREO SCREW HEAD AND SADDLE HAD DISASSOCIATED FROM THE SCREW SHANK. A REVISION WAS NEEDED TO REMOVE AND REPLACE THE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 18825949 ↗MalfunctionJan 23, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REMOVE A CREO MIS SCREW HEAD THAT HAD SEPARATED FROM THE SHANK POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRALIA.
Patient problems: Spinal Column Injury
MAUDE report 18562910 ↗MalfunctionApr 13, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT A CREO MIS SCREW HEAD POPPED OFF POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 11658862 ↗
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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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