BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR CERVICAL FUSION TRAY SCREW DRIVER

    MDR report key: 11769034 · Received May 3, 2021

    Report

    Report Number
    MW5101136
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 30, 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 REMOVING A SCREW, THE END OF THE SCREW DRIVER BROKE OFF. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656038 POSTERIOR CERVICAL FUSION TRAY SCREW DRIVER POSTERIOR CERVICAL SCREW SYSTEM NKG L&K BIOMED CO., LTD. CS01-0607 13079002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other