BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTMED SI-915, 2011

    MDR report key: 7780587 · Received August 14, 2018

    Report

    Report Number
    9681479-2018-00004
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 1, 2018
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EBW
    PMA / PMN Number
    K060287
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS HEAVILY SOILED ACCORDING TO INADEQUATE REPROCESSING. NO PRODUCT FAILURES HAVE BEEN DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR DOES NOT FUNCTION. THE HANDPIECE DRILL DID NOT TURN WHEN PRESSING DOWN THE FOOT PEDAL OF THE MOTOR. THIS ERROR OCCURED DURING THE PROCEDURE AND THE DOCTOR WAS UNABLE TO COMPLETE IT. THE PATIENT UNDERWENT ANESTHESIA HAD A HOLD 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
    623938 IMPLANTMED SI-915, 2011 DENTAL MOTOR EBW W&H DENTALWERK BUERMOOS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other