BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 3040146 · Received April 3, 2013

    Report

    Report Number
    2021898-2013-00124
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF PRODUCT PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PT HAD REJECTED THE IMPLANT. ACCORDING TO THE REPORT, IT WAS A FOREIGN BODY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136821 DUREPAIR DURA SUBSTITUTE GXQ - DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R