BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL USA

    MDR report key: 1883230 · Received October 20, 2010

    Report

    Report Number
    3005739886-2010-00003
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    SPINAL USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON LOCKING DOWN SCREW, THE SURGEON NOTICED THAT THE TIP OF THE DRIVER HAD FRACTURED OFF INSIDE THE PEDICLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL USA CANNULATED SCREWDRIVER HXX SPINAL USA 09-9003 2314TS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR