CREO 1067.4880Recalls & reported problems
Globus Medical, Inc. · 8.5 x 80mm Cannulated Screw, Modular, CREO AMP · Class 2
All models of CREO (100)
Data updated Oct 16, 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 00889095024135), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Mechanics Altered1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2023Mechanics Altered; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT DURING A REVISION SURGERY 3 CREO THREADED 6.5X45MM POLYAXIAL SCREWS AT T11/T12 AND 3 CREO AMP 8.5X80MM MODULAR CANNULATED SCREWS AT THE ILLIAC WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN (B)(6).
Patient problems: Failure of Implant
MAUDE report 16546149 ↗
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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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