BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SCREW DRIVER (C-SCREW)

    MDR report key: 12711512 · Received October 27, 2021

    Report

    Report Number
    MW5105000
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 25, 2021
    Report Date
    October 25, 2021
    Manufacturer
    L&K BIOMED CO., LTD.
    Product Code
    NKG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO REMOVE A SCREW IN THE SPINE, DR. BROKE SCREW DRIVER. LNK POSTERIOR CERVICAL TRAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606254 QUICK SCREW DRIVER (C-SCREW) POSTERIOR CERVICAL SCREW SYSTEM NKG L&K BIOMED CO., LTD. CS01-0604 1307860
    1606255 SEMI-REDUCTION POLY SCREW DRIVER SCREWDRIVER HXX L&K BIOMED CO., LTD. CS01-0609 14031700

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR