CREO 5156.1800Recalls & reported problems
Globus Medical, Inc. · CREO DLX Polyaxial Screw, 8.5x100mm · Class 2
All models of CREO (100)
Data updated Oct 18, 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 00889095789072), received between Oct 5, 2022 and Jan 6, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2023Break
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE (2) CREO DLX SCREWS BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 16111371 ↗MalfunctionOct 5, 2022Break
IT WAS REPORTED THAT (2) CREO DLX POLYAXIAL SCREWS WERE FOUND BROKEN BILATERALLY POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 15542147 ↗
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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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