BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV SYS PED. W/SA 25 A. PRECHAMBER

    MDR report key: 3883079 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00100
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Report Date
    February 18, 2014
    Manufacturer
    CHRISTOPH MEITHKE GMBH & CO
    Product Code
    JXG
    PMA / PMN Number
    K062009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MANUFACTURING SITE EVALUATION: MANUFACTURING RECORDS FOR THIS DEVICE WERE CHECKED AND ALL PARAMETERS CHECKED DURING PRODUCTION PASSED INSPECTION. ADJUSTMENT TESTS WERE CARRIED OUT ON THE DEVICE USING STANDARD ADJUSTMENT AND MEASUREMENT TOOLS. THE BREAK FUNCTION IS DAMAGED. THE MEMBRANE OF THE HOUSING IS DEFORMED. THIS IS LIKELY THE RESULT OF EXCESSIVE POWERFUL USE OF THE ADJUSTMENT INSTRUMENT PRIOR TO IMPLANTATION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). VALVE IS NOT ADJUSTABLE PRE-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103847 PROGAV SYS PED. W/SA 25 A. PRECHAMBER JXG CHRISTOPH MEITHKE GMBH & CO FV442T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other