QUARTEX 1149.4522Recalls & reported problems
Globus Medical, Inc. · QUARTEX 4.5mm Polyaxial Screw, 22mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095355741), received between Apr 6, 2021 and Mar 5, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Separation1
- Mechanical Problem1
Patient problems
- Insufficient Information1
- Oversedation1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT REVISION WAS NEEDED TO REPLACE QUARTEX POLYAXIAL SCREWS THAT WERE FOUND BROKEN POST OPERATIVELY.
Patient problems: Oversedation
MAUDE report 18837861 ↗MalfunctionMar 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A QUARTEX 4.5MM POLYAXIAL SCREW HAS BROKEN POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18821699 ↗InjuryApr 6, 2021Break
IT WAS REPORTED THAT A REVISION WAS DONE FOR TWO QUARTEX SCREWS BROKE POST OPERATIVELY, CAUSING PATIENT PAIN.
Patient problems: Pain
MAUDE report 11622925 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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