BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1030489-2011-00533

    MDR report key: 2082672 · Received May 10, 2011

    Report

    Report Number
    1030489-2011-00533
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    December 7, 2007
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN PROVIDED TO MEDTRONIC FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT SPINAL SURGERY AND RECIEVED A PEDICLE SCREW FIXATION DEVICE. AP PROXIMATELY 5 MONTHS POST-OP, X-RAYS REVEALED A BROKEN PEDICLE SCREW IN THE L5-S1 AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWP MEDTRONIC SOFAMOR DANEK USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1