BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 3931631 · Received June 24, 2014

    Report

    Report Number
    2953749-2014-00244
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    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 PT REPORTED THE SYMPTOM OF UNEXPECTED LOSS OF A PERMANENT TOOTH # 24. SINCE TOOTH LOSS IS CONSIDERED TO BE "PERMANENT DAMAGE TO A BODY STRUCTURE" AND OCCURRED DURING THE USE OF THE INVISALIGN SYSTEM, THIS IS BEING REPORTED AS AN MDR.

    Description of Event or Problem · 1

    THE PT REPORTED THE SYMPTOM OF UNEXPECTED LOSS OF A PERMANENT TOOTH # 24 (LOWER LEFT CENTRAL INCISOR). THE PT REPORTED VISITING A PERIODONTIST DUE TO THE REPORTED SYMPTOM. THE TREATING DOCTOR DEFINED THIS EVENT AS A COSMETIC PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368525 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. VIVERA RETAINER 11794305

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other