BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE 2.5 X 2.5CM

    MDR report key: 1638553 · Received March 22, 2010

    Report

    Report Number
    2021898-2010-00050
    Event Type
    Injury
    Date Received
    March 22, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 23, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES AND THE STERILIZATION RECORDS FOR LOT 0906021 WERE WITHIN SPECIFICATIONS. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR THIS LOT. AS A RESULT, THE SOURCE OF THE REPORTED BACTERIA IS UNKNOWN. 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

    A PATIENT HAD A REACTION A FEW DAYS AFTER A SURGERY IN WHICH DUREPAIR WAS USED AS ONE OF MANY PRODUCTS. THE DUREPAIR GRAFT WAS SUBSEQUENTLY EXPLANTED AND SENT TO THE LAB FOR TESTING. THE RESULTS INDICATED CULTURES OF BACTERIA ON BOTH SIDES OF THE DUREPAIR GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUREPAIR DURA SUBSTITUTE 2.5 X 2.5CM GXQ MEDTRONIC NEUROSURGERY NA 0906021

    Patients

    Seq Age Sex Outcome Treatment
    1