BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATION SYSTEM

    MDR report key: 2973640 · Received February 22, 2013

    Report

    Report Number
    8030965-2013-00582
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    PMA / PMN Number
    K110604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE THREE-WAY VALVE PACKAGE WAS MISSING, WHICH IS PART OF THE INFLATION KIT FOR THE VERTEBRAL BALLOON SYSTEM. THIS IS WAS CONFIRMED BY THE SURGERY NURSE. THIS IS 1 OF 1 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78656 INFLATION SYSTEM INFLATION SYSTEM NDN SYNTHES GMBH 2041182

    Patients

    Seq Age Sex Outcome Treatment
    1