BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE

    MDR report key: 3941015 · Received June 18, 2014

    Report

    Report Number
    3004893332-2014-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K101848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) OF DEPUY SPINE (A COMPETITOR) CONTACTED (B)(4) ON (B)(6)2014 TO REQUEST A CERVICAL REMOVAL TOOL. HE STATED HE HAS A "BROKEN SCREW REMOVAL". HE THEN REFUSED TO GIVE ANY INFO ABOUT THE PT, INITIAL OR REMOVAL SURGERIES, OR EVENTS READING UP TO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358292 SAPPHIRE CERVICAL SCREW KWQ SPINAL ELEMENTS, INC. 26X4X-0XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R