CREO 1119.0150Recalls & reported problems
Globus Medical, Inc. · 5.5 Closed Polyaxial Tulip, CREO AMP · 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 00889095059694), received between Feb 3, 2022 and Feb 3, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection2
- Migration or Expulsion of Device2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Loose or Intermittent Connection; Migration or Expulsion of Device
IT WAS REPORTED THAT A CREO SCREW HEAD HAS LOOSENED WITH SUBSEQUENT ROD MIGRATION 6 WEEKS POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 13445077 ↗MalfunctionFeb 3, 2022Loose or Intermittent Connection; Migration or Expulsion of Device
IT WAS REPORTED THAT A CREO SCREW HEAD HAS LOOSENED WITH SUBSEQUENT ROD MIGRATION 6 WEEKS POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 13445075 ↗
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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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