CREO 1067.0010Recalls & reported problems
Globus Medical, Inc. · CREO 4.75 Threaded Locking Cap · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095012958), received between Dec 9, 2020 and Jun 17, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation2
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2021Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY WAS COMPLETED DUE TO CREO LOCKING CAPS BECOMING LOOSE POST-OPERATIVELY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12017746 ↗MalfunctionDec 9, 2020Material Separation
IT WAS REPORTED THAT MULTIPLE LOCKING CAPS HAVE POPPED OFF POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10979651 ↗MalfunctionDec 9, 2020Material Separation
IT WAS REPORTED MULTIPLE LOCKING CAPS HAVE POPPED OFF POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10979629 ↗MalfunctionDec 9, 2020Detachment of Device or Device Component
IT WAS REPORTED MULTIPLE LOCKING CAPS HAVE POPPED OFF POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 10979599 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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