BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTMED

    MDR report key: 5165212 · Received October 19, 2015

    Report

    Report Number
    9681479-2015-00003
    Event Type
    Injury
    Date Received
    October 19, 2015
    Date of Event
    June 3, 2015
    Report Date
    October 15, 2015
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Product Code
    EBW
    PMA / PMN Number
    K052741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE, W&H DENTALWERK BURMOS (B)(4) AS THE MANUFACTURER, BECAME AWARE OF THE ADVERSE EVENT DURING OUR PERIODICAL MAUDE DATABASE RESEARCH. WE HAVE NOT RECEIVED ANY INFORMATION FROM (B)(6) ABOUT THIS EVENT. ACCORDING TO THE IFU (IMPLANTMED SI-923/SI-915) W&H CONSIDERS THAT A SYSTEM FAILURE DOES NOT CONSTITUTE A CRITICAL FAULT. ADDITIONALLY, IN THE SAFETY NOTES OF THE IFU IS STATED, THAT YOU HAVE TO CHECK THE IMPLANTMED, THE STRAIGHT OR CONTRA-ANGLE HANDPIECE AND THE MOTOR WITH CABLE FOR DAMAGE AND LOOSE PARTS EACH TIME BEFORE USING. DO NOT OPERATE THE IMPLANTMED IF IT IS DAMAGED.

    Description of Event or Problem · 1

    (B)(6) ALREADY REPORTED FOLLOWING NARRATIVE TO FDA. AFTER PATIENT WAS ANESTHETIZED, IT WAS DISCOVERED THE IMPLANTED DRILL, PROVIDED BY (B)(6) DID NOT FUNCTION. THE SURGERY WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689178 IMPLANTMED DENTAL DRILL EBW W & H DENTALWERK BUERMOOS GMBH SI-915

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization