BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA GUARD DURAL REPAIR PATCH WITH APEX PROCESSING

    MDR report key: 1033105 · Received April 23, 2008

    Report

    Report Number
    2183620-2008-00005
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 23, 2008
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE LOT NUMBERS NOT REPORTED TO MANUFACTURER THEREFORE, MANUFACTURE AND EXPIRATION DATES UNK.

    Description of Event or Problem · 1

    IN 2008, PT HAD DURA GUARD IMPLANTED DURING A CHARI MALFORMATION SURGERY. APPROX 1 MONTH LATER, THE PT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF HEADACHE, VOMITING, NECK ACHE, PHOTOPHOBIA, AND LACK OF APPETITE. SURGEON OBTAINED A SPINAL SAMPLE WHICH WAS TESTED FOR BACTERIAL & VIRAL MENINGITIS. NO PATHOGENS WERE FOUND IN THE SPINAL FLUID. SURGEON SUSPECTED ASEPTIC MENINGITIS. HE PRESCRIBED ANTIBIOTICS AND STEROIDS TO TREAT THE SYMPTOMS. PT IMPROVED, BUT HAD DOUBLE VISION AND TONGUE MALADIES DUE TO CRANIAL NERVE 12 INVOLVEMENT. SURGEON THEN EXPLANTED THE DURA GUARD THE NEXT MONTH. PT HAS RECOVERED WITHOUT FURTHER PROBLEMS AND NO OUTSTANDING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA GUARD DURAL REPAIR PATCH WITH APEX PROCESSING DURAL REPAIR PATCH GXQ SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention