CREO 1119.0000Recalls & reported problems
Globus Medical, Inc. · 5.5 Locking Cap, CREO · Class 2
All models of CREO (100)
Data updated Oct 18, 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 00889095059489), received between Nov 20, 2020 and Feb 29, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Device Slipped2
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A CREO LOCKING CAP DISLODGED FROM THE SCREW POST-OPERATIVELY REQUIRING REVISION SURGERY. THE SURGEON INDICATED DURING REVISION THAT BOTH SIDES OF THE CONSTRUCT WERE LOOSE.
Patient problems: Insufficient Information
MAUDE report 18810830 ↗MalfunctionNov 3, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE CREO LOCKING CAPS AND A ROD THAT HAD SLIPPED 1 MONTH POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747677 ↗MalfunctionJan 4, 2021Device Slipped
IT WAS REPORTED THAT THE ROD SLIPPED OUT OF THE SCREW HEAD AT S1.
Patient problems: Insufficient Information
MAUDE report 11113579 ↗MalfunctionNov 20, 2020Device Slipped
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE FOR 2 S1 LOCKING CAPS THAT ALLOWED FOR THE ROD TO SLIP POST-OPERATIVELY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10879452 ↗
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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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