CREO 1119.0050Recalls & reported problems
Globus Medical, Inc. · CREO 5.5 Locking Cap NS · 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 00889095733082), received between Apr 19, 2021 and Jun 29, 2021 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Migration1
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.
MalfunctionJun 29, 2021Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY WAS COMPLETED DUE TO CREO LOCKING CAPS LOOSENING POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 12086019 ↗MalfunctionApr 19, 2021Migration
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE FOR A ROD THAT HAD MIGRATED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 11689135 ↗
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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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