BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14MM DISTRACTION SCREWS

    MDR report key: 525661 · Received February 20, 2004

    Report

    Report Number
    1423507-2004-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2004
    Date of Event
    January 21, 2004
    Report Date
    February 20, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GZT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR. WAS CONDUCTING A CERVIAL CORPECTOMY WITH FUSION. WHEN HE WAS IN THE PROCESS OF SCREWING THE DISTRACTION SCREW INTO THE VETEBRAL BODY WITH THE V. MUELLER-NEURO SPINE SCREW DRIVER(S-0106), THE SCREW BROKE. BY HIS ESTIMATE, THE SCREW WAS IN ABOUT 3 THREADS WHEN IT BROKE FLUSH TO THE VERTEBRAL BODY. THE DOCTOR COULD NOT TAKE OUT THE SCREW WITHOUT DAMAGING THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14MM DISTRACTION SCREWS 14MM DISTRACTION SCREWS GZT CARDINAL HEALTH S-0089 112847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other