BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    765DC INTRAORAL X-RAY

    MDR report key: 1083827 · Received July 29, 2008

    Report

    Report Number
    3004115000-2008-00014
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EAP
    PMA / PMN Number
    K992610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT OR USER INJURY. RESULTS: THE SCREWS CONNECTING THE TUBEHEAD TO THE YOKE WERE NOT STAYING SECURE. CONCLUSIONS: THE SCISSOR ARM AND TUBEHEAD WILL BE REPLACED UNDER WARRANTY.

    Description of Event or Problem · 1

    FOUR SCREWS THAT ATTACH THE TUBEHEAD WERE REPEATEDLY COMING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 765DC INTRAORAL X-RAY DENTAL X-RAY EQUIPMENT EAP GENDEX DENTAL SYSTEMS 110-0155G1

    Patients

    Seq Age Sex Outcome Treatment
    1