BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WH-915 IMPLANTMED SI-915 STARTER KIT

    MDR report key: 4051797 · Received August 11, 2014

    Report

    Report Number
    1060818-2014-00001
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    W&H IMPEX, INC.
    Product Code
    GEY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A DENTAL IMPLANT SURGICAL PROCEDURE, THE CLINICIAN DROVE AN IMPLANT INTO THE PT'S SINUS CAVITY WHILE USING ITEM WH-915, W&H SURGICAL DRILL MOTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476599 WH-915 IMPLANTMED SI-915 STARTER KIT WH-915 STARTER KIT GEY W&H IMPEX, INC. WH-915 01736/30784

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention