BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARE MOTOR COMPLETE, IMPLANTMED SI-915, 2011, 1.8 M

    MDR report key: 7735425 · Received July 31, 2018

    Report

    Report Number
    0001038806-2018-00713
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 31, 2018
    Manufacturer
    W&H IMPEX INC.
    Product Code
    EBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR (06631600) DOES NOT FUNCTION. THE HANDPIECE DRILL DID NOT TURN WHEN PRESSING DOWN ON THE FOOT PEDAL OF THE MOTOR. THIS ERROR OCCURRED DURING THE PROCEDURE AND THE DOCTOR WAS UNABLE TO COMPLETE IT. THE PATIENT UNDERWENT ANESTHESIA AND A HOLE HAD BEEN DRILLED IN THE MOUTH. THE PATIENT HAD TO RETURN ON A DIFFERENT DAY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578516 SPARE MOTOR COMPLETE, IMPLANTMED SI-915, 2011, 1.8 M DENTAL MOTOR EBW W&H IMPEX INC. 25481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention