BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOCLEAR X PEDICLE SCREW SYSTEM

    MDR report key: 14052482 · Received April 7, 2022

    Report

    Report Number
    MW5108835
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    November 30, 2021
    Report Date
    April 5, 2022
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARBOFIX CARBOCLEAR X (NEW SYSTEM) HAD A TULIP BREAK OFF FROM THE SCREW. THIS IS A BRAND NEW SYSTEM THAT CONTINUES TO HAVE QUALITY ISSUES. THE SCREW WAS BROKEN ONCE THE TULIP SNAPPED OFF AND NEEDED TO DRILL THE SCREW OUT LEAVING DEBRIS IN THE PEDICLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443740 CARBOCLEAR X PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB CARBOFIX ORTHOPEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention