BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 1011387 · Received March 11, 2008

    Report

    Report Number
    2021898-2008-00065
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT LEAKED, AND THE PT DEVELOPED A PSEUDOMENINGOCELE SEVEN WEEKS AFTER IMPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1