BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO PIECE OSVII SYSTEM WITH ANTECHAMBER

    MDR report key: 2875223 · Received December 13, 2012

    Report

    Report Number
    9612007-2012-00040
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K081773
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT HAD TO BE RETURNED TO SURGERY TO REPLACE A NON-FUNCTIONING VALVE. THE VALVE HAD NO FLOW. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWO PIECE OSVII SYSTEM WITH ANTECHAMBER N/A JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0153892

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other