BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 3040161 · Received April 3, 2013

    Report

    Report Number
    2953749-2013-00078
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THE REPORTED SYMPTOMS OF AN UPSET STOMACH, NAUSEA, DIZZINESS, SWELLING AND TENDERNESS OF THE FEET, AND DISCOLORATION OF THE PT'S URINE ARE NOT CONSIDERED SERIOUS IN NATURE OR POTENTIALLY LIFE THREATENING TO THE PT. SINCE THE PT'S GENERAL PHYSICIAN (GP), REPORTED THAT THE BLOOD WORK TESTS CONFIRMED A TOXIC EVEN WAS AFFECTING HIS LIVER. THIS EVENT IS BEING FILED. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE PT LIVER AILMENT. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED EVENT, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE PT REPORTED SYMPTOMS OF AN UPSET STOMACH, NAUSEA, DIZZINESS, SWELLING AND TENDERNESS OF THE FEET, AND DISCOLORATION OF THE PT'S URINE. THE PT INDICATED THAT HE VISITED HIS GENERAL PHYSICIAN (GP), WHO RAN A BATTERY OF TESTES INCLUDING BLOOD WORK. THE BLOOD WORK TESTS CONFIRMED A TOXIC EVENT WAS AFFECTING HIS LIVER. THE PT STOPPED USING THE ALIGNERS ON (B)(6) 2013 AND GOT PROGRESSIVELY BETTER. THE PT RESUMED THE INVISALIGN TREATMENT ON (B)(6) 2013, BUT BEGAN TO EXPERIENCE THE SAME SYMPTOMS AS BEFORE AND DECIDED TO DISCONTINUED THE TREATMENT. THE PT REPORTED THAT ALL THE SYMPTOMS DISAPPEAR AS SOON AS THE ALIGNERS WERE REMOVED. THE PT HAS NO PRIOR MEDICAL OR ALLERGY HISTORY AND IS NOT CURRENTLY TAKING AN MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137000 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 8436841

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other