BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATION SYSTEM

    MDR report key: 3180229 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03677
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    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

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THIS DEVICE WAS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. OUR INVESTIGATION HAS SHOWN THAT THE 3WAY VALVE IS INDEED MISSING AS COMPLAINED. AFTERWARDS IT IS IMPOSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. IT IS POSSIBLE THAT A HUMAN MISTAKE DURING THE HAND OPERATED PACKAGING CAUSED THIS OCCURRENCE. A CAPA DETERMINATION WAS OPENED AND THE RESPONSIBLE EMPLOYEES WERE MADE AWARE OF THIS COMPLAINT AND WERE TRAINED TO AVOID SUCH AN OCCURRENCE IN THE FUTURE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED THAT THE 3 WAY CONNECTOR OF THE INFLATION SYSTEM FOR THE VERTEBRAL BODY BALLOON WAS MISSING. THE SURGEON USED ANOTHER DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280278 INFLATION SYSTEM NDN SYNTHES GMBH 2071553

    Patients

    Seq Age Sex Outcome Treatment
    1