BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGIN SYSTEM

    MDR report key: 2412988 · Received January 9, 2012

    Report

    Report Number
    2953749-2011-00181
    Event Type
    Other
    Date Received
    January 9, 2012
    Date of Event
    November 4, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BE EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THE PATIENT INDICATED BEING RECENTLY DIAGNOSED WITH ORAL CANCER. THE ALIGNERS WERE USED APPROXIMATELY FOR SIX MONTHS. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE PATIENT CONDITION. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE ORAL CANCER DIAGNOSIS, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE TREATMENT STARTED IN (B)(6) 2011. ON (B)(6) 2011, THE PATIENT REPORTED A BLISTER OR A CALLUS ON THE RIGHT SIDE OF HER TONGUE. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT REPORTED SEEING AN ONCOLOGIST WHO PERFORMED A BIOPSY AND CONFIRMED THAT THE PATIENT HAD ORAL CANCER. DR (B)(6) SAID, THERE WAS NO RELEVANT MEDICAL OR FAMILY HISTORY, NO HARMFUL HABITS (SUCH AS SMOKING OR DRINKING) OR INITIAL SIGNS OR SYMPTOMS OF CANCER NOTED DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGIN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN ASSIST 84865895

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other