BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VBS W/BALLOON SM

    MDR report key: 3091370 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02102
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT UNDERWENT A TECHNICAL ANALYSIS AND DOCUMENTATION TO DETERMINE WHETHER THE ISSUE WAS DUE TO A MANUFACTURING PROCESS. AN ANALYSIS OF THE DEVICE SHOWED THAT THERE WAS NO NON-CONFORMITY OF THE INSTRUMENT. THEREFORE, A ROOT CAUSE CONCERNING THE DESCRIBED FAILURE MODES CAN NOT BE IDENTIFIED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE STENT COULD NOT BE OPENED COMPLETELY IN POSITION. IT WAS REPORTED THAT THIS OCCURRED BECAUSE THERE WAS A HOLE IN THE BALLOON. THIS OCCURRED WHEN THE VERTEBRAL BODY STENT (VBS) WAS INTRODUCED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193735 VBS W/BALLOON SM FZX SYNTHES GMBH 0911035

    Patients

    Seq Age Sex Outcome Treatment
    1