CREO 5119.1737Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 7.5 x 35mm Polyaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095104660), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SURGEON DID A L3-S1 CREO ONE REVISION AS S1 SCREWS WERE LOOSE. THE PLAN WAS TO REPLACE SCREWS AT S1 AND ADD S2A1 SCREWS THEN REMOVE SET SCREWS AND RODS FROM OLD CONSTRUCT AND PLACE A LONGER ROD CONNECTING ALL SCREWS. THE SET SCREWS ON 5 SCREWS AND ONE SIDE BY SIDE ROD CONNECTOR WERE COLD WELDED AND COULDN'T BE REMOVED. A CUSTOM HEAD SPLAYER WAS USED AND SET SCREWS WERE THEN EASILY REMOVED. THE 5 SCREWS THAT WERE REMOVED WERE REPLACED WITH LARGER DIAMETER SCREWS. THE S1 CREO ONE SCREWS WERE REPLACED WITH SI BONE GRANITE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643629 ↗
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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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