CREO 5119.1747Recalls & reported problems
Globus Medical, Inc. · CREO® Threaded 7.5 x 45mm Polyaxial Screw · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889095104721), received between Jan 6, 2023 and Aug 20, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Migration1
- Use of Device Problem1
Patient problems
- Spinal Column Injury2
- Fall1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2025Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE TO REMOVED AND REPLACE A CREO SCREW THAT FRACTURED. THIS EVENT TOOK PLACE IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 22854030 ↗MalfunctionMar 14, 2025Fracture; Fracture
IT WAS REPORTED THAT A CREO THREADED SCREW WAS FOUND BROKEN DURING A REVISION SURGERY POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 21609614 ↗MalfunctionFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE A CREO THREADED SCREW DUE TO PATIENT INFECTION POST OPERATIVELY.
Patient problems: Unspecified Infection
MAUDE report 21334695 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A REVISION SURGERY THE SCREW HEAD OF A CREO THREADED POLYAXIAL SCREW POPPED OFF WHEN INSTALLING A ROD AT L4 AND THE REMAINDER WAS LEFT IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18837670 ↗MalfunctionJan 6, 2023Migration
IT WAS REPORTED THAT A REVISION WAS NEEDED DUE TO POST OPERATIVE MIGRATION OF A CREO THREADED SCREW AFTER A PATIENT FALL.
Patient problems: Fall
MAUDE report 16115283 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.