BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN ALIGNERS

    MDR report key: 4934643 · Received July 21, 2015

    Report

    Report Number
    2953749-2015-00467
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 21, 2015
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS. THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN SYS ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENT SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT'S TOOTH WAS REMOVED, PERMANENT DAMAGE TO A BODY STRUCTURE, AND INVISALIGN SYS PRODUCT WAS BEING USED AT THAT TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SYMPTOM OF A BONE LOSS ON TOOTH #25; LOWER LEFT CENTRAL INCISOR. THE TREATING DR. FOUND THAT TOOTH #25 WAS FRACTURED AND HAD TO BE REPLACED WITH A PERMANENT BRIDGE TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT DID NOT REPORT TALKING OR BEING PRESCRIBED ANY MEDICATION DUE TO THE REPORTED SYMPTOMS. THE TREATMENT WAS NOT DISCONTINUED AND THE PATIENT AGREED TO CONTINUE THE TREATMENT. THE TREATING DR. INDICATED THAT THESE IS NO EVIDENCE OF PHYSICAL TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470789 INVISALIGN ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 15510178

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other