BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL TOP DRIVER SHAFT (G00110)

    MDR report key: 1349863 · Received March 23, 2009

    Report

    Report Number
    1718476-2009-00001
    Event Type
    Injury
    Date Received
    March 23, 2009
    Date of Event
    January 19, 2009
    Report Date
    March 23, 2009
    Manufacturer
    RMO, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    LAPSED TIME FROM THE INITIAL REPORT UNTIL TIME OF NOTIFICATION WAS DUE TO HOSPITALIZATION OF RMO REGULATORY AFFAIRS EMPLOYEE FOR MEDICAL TREATMENT OF A SERIOUS MEDICAL CONDITION. A FORMER REGULATORY AFFAIRS EMPLOYEE WAS BROUGHT BACK TO ASSIST IN COMPLETING THE REPORTING PROCESS. THE EXPECTATION IS THE RETURN OF THE QUALITY ENGINEER APPROX MID 2009.

    Description of Event or Problem · 1

    THE 1.6X6MM BUTTON TO TAD BROKE UPON PLACEMENT TO THE DISTAL OF TOOTH #28. BONE WAS DENSE. PT HAD A LOT OF TORQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TOP DRIVER SHAFT (G00110) TAD DZE RMO, INC. G00110

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention TAD REMOVAL BY GENERAL DENTIST