BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA BOVINE PERICARDIUM DURAL GRAFT

    MDR report key: 5590410 · Received April 20, 2016

    Report

    Report Number
    3002719998-2016-00009
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 21, 2016
    Manufacturer
    RTI SURGICAL, INC
    Product Code
    GXQ
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFIERS WERE NOT PROVIDED TO RTI IN ORDER TO PERFORM AN INVESTIGATION AND RE-REVIEW OF MANUFACTURING RECORDS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC. (RTI) AND (B)(4), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON (B)(6) 2016 INDICATING A PEDIATRIC AGE PATIENT DEVELOPED CHEMICAL MENINGITIS AFTER IMPLANTATION OF BOVINE PERICARDIUM DURAL GRAFT. AN EXTENSIVE TREATMENT PLAN WAS UTILIZED TO TREAT THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, RTI HAS NOT RECEIVED ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243742 INTEGRA BOVINE PERICARDIUM DURAL GRAFT BOVINE PERICARDIUM DURAL GRAFT GXQ RTI SURGICAL, INC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other