BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANAP LASER

    MDR report key: 2814691 · Received October 26, 2012

    Report

    Report Number
    MW5027398
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    September 1, 2009
    Report Date
    October 26, 2012
    Manufacturer
    MILLENNIUM DENTAL TECHNOLOGIES INC
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS DX WITH PERIODONTITIS DISEASE AND HAD LANAP PROCEDURE IN (B)(6) 2009. PT'S GUMS WERE NOT HEALING WELL. PT HAD REPEAT LANAP PROCEDURES IN (B)(6) 2010. PT WAS REFERRED TO DR (B)(6), WHICH HAS DX PT WITH LOOSE TEETH, SLOUGHING OF GUMS AND BONES OF HER TEETH. PT HAD BIOPSY DONE, RESULTS INDICATE NECROSIS OF THE GUMS. PT'S NEW DOCTOR THINKS THAT THE LANAP PROCEDURE WAS DONE TOO MANY TIMES WHICH HAS CAUSED THE PT. PERMANENT DAMAGE. PT HAD A SPLINTING PROCEDURE ON HER TEETH DONE, BUT IT IS NOT WORKING. PT WILL LIKELY LOOSE ALL HER TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANAP LASER LASER GEX MILLENNIUM DENTAL TECHNOLOGIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention