BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 2924977 · Received January 17, 2013

    Report

    Report Number
    2021898-2013-00015
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. IT WAS REPORTED THAT ANCILLARY PRODUCTS WERE USED IN CONJUNCTION WITH DUREPAIR. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE WARN THAT "ANIMAL STUDY RESULTS SUGGEST THAT THE FOREIGN BODY RESPONSE ASSOCIATED WITH THE USE OF SEALANTS AND HEMOSTATIC AGENTS IN CONJUNCTION WITH DUREPAIR MAY BE MORE PRONOUNCED THAN USE OF DUREPAIR ALONE. THIS RESPONSE MAY INCREASE THE INCIDENT RATES OF KNOWN RISKS OF DURA SUBSTITUTES, PARTICULARLY IN HIGH PRESSURE GRADIENT APPLICATIONS. IF INTENDING TO USE ANCILLARY PRODUCTS WITH DUREPAIR, ENSURE THE PRODUCTS ARE APPLIED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE." IT IS UNK WHAT CAUSED OR CONTRIBUTED TO THE REPORTED REACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN WAS CONCERNED THAT THEIR PT MAY HAVE POSSIBLY HAD A REACTION TO THE IMPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25608 DUREPAIR DURA SUBSTITUTE GXQ - DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening