CREO 1067.4745Recalls & reported problems
Globus Medical, Inc. · 7.5 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095023879), received between Mar 5, 2024 and Apr 21, 2026 — classified as 1 injury, 3 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
- Device Slipped1
- Migration1
Patient problems
- Spinal Column Injury2
- Insufficient Information1
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Migration
IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT A SPINAL PROCEDURE USING CREO MIS. THEN ON (B)(6) 2026 THE REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF PEDICLE SCREWS AT L5. THE FIXATION AREA WAS EXTENDED FROM L2 TO ILIAC. THE SALE REP COMMENTED THAT THE PATIENT'S BONE QUALITY WAS POOR. THE LOCKING CAPS WERE OBTAINED, BUT THE LOOSE MIS SCREWS WERE NOT.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 24940788 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A CREO AMP 7.5X45MM MODULAR CANNULATED SCREW THAT MIGRATED POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837673 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A CREO AMP MODULAR SCREW WAS FOUND TO HAVE DAMAGED THREADS DURING SURGERY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837333 ↗MalfunctionMar 5, 2024Device Slipped; Device Slipped
IT WAS REPORTED THERE WAS A REVISION SURGERY NEEDED TO REPLACE A CREO SCREW THAT WAS FOUND LOOSE AT L5 POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834290 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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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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