BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2001118 · Received February 17, 2011

    Report

    Report Number
    2953749-2011-00019
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 TO LABELED INDICATIONS. THE PT'S REPORTED SYMPTOMS DID NOT REQUIRE MEDICAL TREATMENT, NOR WAS MEDICATION PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS. THE PT DECIDED TO DISCONTINUE USE OF THE PRODUCT. IN THIS CASE THERE WAS NO EVIDENCE PROVIDED THAT DEMONSTRATES THAT THE ALIGNER WAS THE CAUSAL AGENT OR CONTRIBUTED TO THE PT'S REPORTED SYMPTOMS. SINCE THE ALIGN PRODUCT WAS BEING USED DURING THE ONSET OF THE PT'S SYMPTOMS, THIS EVENT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE ALIGNERS WERE DELIVERED ON (B)(6) 2011, THE PT REPORTED SYMPTOMS OF PAIN IN HER JAW, HEADACHES, CHEST PAIN AND HIGH BLOOD PRESSURE (INCREASED). THE PT DISCONTINUED TREATMENT ON (B)(6) 2011. THE TREATING PHYSICIAN BELIEVES THAT THIS WAS A LIFE THREATENING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC INVISALIGN FULL 80702159

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening