CREO 1067.4645Recalls & reported problems
Globus Medical, Inc. · 6.5 x 45mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889095023688), received between Feb 29, 2024 and Jan 20, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
- Human-Device Interface Problem1
- Insufficient Device Problem Information1
- Migration1
- Product Quality Problem1
Patient problems
- Insufficient Information3
- Spinal Column Injury3
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE A MISPLACED CREO MIS SCREW THAT WAS CAUSING THE PATIENT DISCOMFORT/PAIN. THIS EVENT OCCURED IN SINGAPORE.
Patient problems: Pain
MAUDE report 24121623 ↗MalfunctionJul 23, 2025Migration; Migration
IT WAS REPORTED THAT A REVISION CASE ON CREO MIS SCREWS OCCURRED DUE TO ONE OF THE SCREWS BECOMING LOOSE.
Patient problems: Spinal Column Injury
MAUDE report 22579553 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE CREO SCREWS THAT WERE FOUND LOOSE POST OPERATIVELY. THIS EVENT OCCURRED IN GERMANY.
Patient problems: Spinal Column Injury
MAUDE report 18837937 ↗MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A CREO AMP SCREW THAT WAS FOUND LOOSE POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18837356 ↗MalfunctionMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THERE WAS A REVISION TO REMOVE AND REPLACE CREO SCREWS DUE TO PATIENT HAVING ADJACENT SEGMENT DISEASE (ASD). THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834240 ↗InjuryMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PEDICLE SCREW WAS NOT PLACED PROPERLY. REVISION SURGERY WAS PERFORMED TO REPOSITION THE SCREW.
Patient problems: Insufficient Information
MAUDE report 18827352 ↗MalfunctionFeb 29, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED DUE TO CREO SCREWS FOUND LOOSE BOTH OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18809569 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
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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