BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.1MM #703 TAPERED BUR

    MDR report key: 1920516 · Received December 4, 2010

    Report

    Report Number
    2027754-2010-00013
    Event Type
    Injury
    Date Received
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    OSTEOMED LP
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REPORT FROM DR.'S OFFICE. DOCTOR WAS USING PRODUCT FOR FIRST TIME. PT REQUIRED ONE STITCH AND ACCORDING TO OFFICE IS CURRENTLY DOING FINE.

    Description of Event or Problem · 1

    DOCTOR WAS TRYING OUT THE OSTEOPOWER SYSTEM AND WAS NOT USED TO THE AMOUNT THAT THE BUR STUCK OUT OF THE HANDPIECE. THE BUR CUT THE PT'S LIP AND REQUIRED ONE STITCH. THE PT IS FINE AND REQUIRES NO FURTHER ATTENTION. THE IFU STATES THAT THE SURGEON SHOULD BE THOROUGHLY FAMILIAR WITH THE PROER OPERATIONS OF THE POWERED SURGICAL INSTRUMENTS AND ACCESSORIES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.1MM #703 TAPERED BUR TAPERED BUR EJL OSTEOMED LP 455-3703 1032027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention USING OSTEOPOWER SYSTEM AT SAME TIME.