BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2 X 2 DUREPAIR DURA SUBSTITUTE

    MDR report key: 2679575 · Received July 27, 2012

    Report

    Report Number
    2021898-2012-00240
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 28, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR LOT 1202048, AND A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE PRODUCT NOTE THAT INFECTIONS ARE A GENERAL RISK OF DURA-RELATED SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PATIENT HAD A REACTION TO A PIECE OF DUREPAIR FROM A CHIARI. ACCORDING TO THE REPORT, THE PATIENT DEVELOPED AN INFECTION CAUSED BY PANTOEAAGGLOMERANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 X 2 DUREPAIR DURA SUBSTITUTE GXQ - DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY 1202048

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O