BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 441832 · Received January 21, 2003

    Report

    Report Number
    2953749-2003-00001
    Event Type
    Injury
    Date Received
    January 21, 2003
    Date of Event
    December 2, 2002
    Report Date
    January 16, 2003
    Manufacturer
    ALIGN TECHNOLOGY
    Product Code
    KMY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE USING AN ALIGNER (CLEAR PLASTIC TRAY DESIGNED TO MOVE TEETH TO CORRECT MALOCCLUSION) PT'S DENTAL CROWN FRACTURED. PT WAS MID TREATMENT (12 OF 37) WHEN THE CROWN FRACTURED AT THE CEJ (GINGIVAL LINE) ON LOWER LATERAL INCISOR. AFTER THE FRACTURE INCIIDENT, A POST/CORE WAS PLACED, CROWN PLACED, AND A NEW IMPRESSION TAKEN FOR CONTINUATION OF INVISALIGN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM ORTHODONTIC APPLIANCE KMY ALIGN TECHNOLOGY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention