CREO 5119.1646SRecalls & reported problems
Globus Medical, Inc. · 6.5x45 HA Coated Screw, Preassembled, CREO 5.5mm · Class 2
All models of CREO (100)
Data updated Oct 18, 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 00889095212723), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE PATIENT COMPLAINED OF "CLICKING" AND RIGHT SIDED PAIN. POST-OPERATIVE CT IMAGING SHOWED ALL SCREWS, RODS, AND CAPS TO BE INTACT. HOWEVER, THE RIGHT S1 AND LS SCREWS APPEARED TO BE SLIGHTLY LATERAL AND LONG. REVISION SURGERY WAS NEEDED TO REPOSITION THE SCREWS.
Patient problems: Insufficient Information
MAUDE report 18831346 ↗
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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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