BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSS CANNULATED SCREW SYSTEM

    MDR report key: 1903502 · Received November 16, 2010

    Report

    Report Number
    3005039508-2010-00020
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    Product Code
    HWC
    PMA / PMN Number
    K060428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER THE SURGEON, TWO SCREWS BROKE POST OPERATIVELY. THE SURGEON HAD DONE A TN FUSION AND THE BONES NEVER FUSED. THE SURGEON SAID, THE PRODUCT WAS NOT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSS CANNULATED SCREW SYSTEM BONE FIXATION SCREWS HWC ORTHOHELIX SURGICAL DESIGN MSD-010-55-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention