BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2093576 · Received April 15, 2011

    Report

    Report Number
    2953749-2011-00042
    Event Type
    Other
    Date Received
    April 15, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THE PTS SYMPTOM OF HEADACHES ARE NOT CONSIDERED SERIOUS IN NATURE, BUT THE REPORTED SYMPTOM OF AIRWAY OBSTRUCTION IS OF A CONCERN AND COULD BE A SIGN OF SOMETHING MORE SERIOUS. THE PT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION OR ATTENTION AND WAS NOT PRESCRIBED OR TOOK ANY MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATING ORTHODONTIST REPORTED TO ALIGN THAT HE BELIEVED THIS WAS A POTENTIAL LIFE THREATENING EVENT, THUS AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    (B)(4) SYSTEM ALIGNERS WERE DELIVERED TO THE PT ON (B)(6) 2011. SIX HOURS LATER THE PT REPORTED HEADACHES AND AIRWAY OBSTRUCTION. THE PT STOPPED TREATMENT FOR TWO DAYS AND SYMPTOMS DISAPPEARED. THE PT TRIED THE ALIGNERS AGAIN AND THE SYMPTOMS REAPPEARED. NO MEDICAL INTERVENTION WAS REQUIRED NOR WERE MEDICATIONS PRESCRIBED OR TAKEN TO ALLEVIATE THE REPORTED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 86443418

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other