BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 5072594 · Received September 11, 2015

    Report

    Report Number
    2953749-2015-00631
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    December 1, 2014
    Report Date
    September 11, 2015
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO TEST METHODS HAVE BEEN PERFORMED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENT SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED HAVING TWO TEETH EXTRACTED (PERMANENT DAMAGE TO A BODY STRUCTURE) AFTER USING THE INVISALIGN SYSTEM ALIGNERS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SYMPTOMS OF TWO CRACKED CROWNS (UNSPECIFIED TEETH), TOOTH INFECTION (UNSPECIFIED TEETH), BONE LOSS, SORE GUMS AND BUMPS ON THE GUMS. THE PATIENT REPORTED VISITING A MEDICAL DOCTOR AND A SPECIALIST DUE TO THE REPORTED SYMPTOMS. THE SPECIALIST REPORTED THE TWO CROWNED TEETH HAD BECOME INFECTED AND NEEDED TO BE EXTRACTED, THE TEETH WERE EXTRACTED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601561 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL (REFINEMENT) 13629716

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other