CREO 5119.1642Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 6.5 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889095104127), received between Nov 19, 2020 and Aug 22, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Loose or Intermittent Connection1
- Mechanical Problem1
- Migration1
- Product Quality Problem1
Patient problems
- Insufficient Information3
- Failure of Implant2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Migration; Migration
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE CREO THREADED SCREWS THAT WERE FOUND BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20042479 ↗MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED DURING A REVISION DUE TO PATIENT COMPRESSION FRACTURE THAT CREO THREADED SCREWS WERE FOUND LOOSE WITH SUBSEQUENT RISE SPACER MIGRATION. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834299 ↗MalfunctionMar 4, 2024Fracture; Fracture
IMAGING TAKEN FIVE WEEKS POST-OPERATIVELY SHOWED THE SCREW HEAD HAD DISASSOCIATED FROM THE SHANK. DURING REVISION SURGERY, THE SURGEON FOUND THE INNER COLLAR BROKEN WITH THE ROD STILL ATTACHED TO THE SCREW HEAD.
Patient problems: Failure of Implant
MAUDE report 18826350 ↗MalfunctionFeb 29, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED DUE TO CREO THREADED SCREWS THAT WERE FOUND BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18810545 ↗MalfunctionNov 19, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE A SCREW WHICH HAD LOOSENED POST-OPERATIVELY CAUSING ADVERSE EFFECTS TO THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 10869274 ↗
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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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