BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTMED SI-915

    MDR report key: 4254125 · Received November 7, 2014

    Report

    Report Number
    9681479-2014-00001
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 14, 2014
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Product Code
    GEY
    PMA / PMN Number
    K052741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DURING A DENTAL TREATMENT ON A PATIENT THE DOCTOR DRILLED AN IMPLANT INTO THE PATIENT'S SINUS CAVITY. THE DOCTOR REPORTED THE EVENT ON (B)(6) 2014. MDR REPORT NUMBER: 1060818-2014-00001. AFTER INVESTIGATING ALL THE AVAILABLE FACTS, W & H CLASSIFIED THE COMPLAINT AS AN ACCIDENTAL USER ERROR BECAUSE THE DOCTOR USED THE WRONG PROGRAM. THE DEVICE IS DESIGNED TO OPERATE WITH FIVE PROGRAM BUTTONS. EACH PROGRAM IS MARKED WITH DIFFERENT SYMBOLS AND WITH THE GEAR REDUCTION. PROGRAM ONE IS MARKED WITH 1:1 AND ALL OTHER PROGRAMS ARE MARKED WITH 20:1 GEAR REDUCTION. THE PUSH BUTTON OF THE ACTIVE PROGRAM IS LIGHTNING. EVERY PROGRAM CHANGE IS SUPPORTED BY A SHORT ACOUSTIC SIGNAL. THE PROGRAM CHANGE BACK TO PROGRAM ONE (1:1) IS SUPPORTED BY A LONG ACOUSTIC SIGNAL. THE FACTORY SETTING AS WELL AS ALL POSSIBLE ADJUSTMENTS ARE DESCRIBED IN THE IFU ON PAGE 30-31. IF THE DENTIST USED THE RIGHT PROGRAM FOR INSERT IMPLANTS, WHICH IS PROGRAM FOUR, IT WOULD BE IMPOSSIBLE FOR HIM TO HAVE THE WRONG SPEED BECAUSE THE PROGRAM IS LIMITED TO 15 RPM'S AND THE SPEED IS NOT ADJUSTABLE BY THE USER. THE PATIENT WOULD NOT HAVE BEEN INJURED IF THE DENTIST FOLLOWED THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718476 IMPLANTMED SI-915 SURGICAL DRILL MOTOR, 76 EBW GEY W & H DENTALWERK BUERMOOS GMBH 16929001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WI-75