BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 X 3 DUREPAIR DURA SUBSTITUTE

    MDR report key: 1023804 · Received April 2, 2008

    Report

    Report Number
    2021898-2008-00082
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 17, 2008
    Report Date
    March 6, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED A PSEUDOMENINGOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 X 3 DUREPAIR DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY NA 0707006

    Patients

    Seq Age Sex Outcome Treatment
    1