BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2640372 · Received June 28, 2012

    Report

    Report Number
    2953749-2012-00169
    Event Type
    Other
    Date Received
    June 28, 2012
    Date of Event
    January 1, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ALIGN TECHNOLOGY INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECS (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THIS PT WAS NOT A CANDIDATE FOR ORTHODONTIC TREATMENT USING THE INVISALIGN SYS, AND SHOULD HAVE BEEN DISCOURAGED DURING TREATMENT PLANNING BASED ON THE PRE-EXISTING CONDITIONS OF BONE LOSS AND PERIODONTAL DISEASE. THE INVISALIGN SYS IS CONTRAINDICATED FOR USE IN PTS WITH ACTIVE PERIODONTAL DISEASE. BASED ON THE INFO REPORTED, THE ORTHODONTIC TREATMENT MAY HAVE CONTRIBUTED TO TOOTH LOSS. HENCE AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE PT STARTED THE TREATMENT ON (B)(6) 2011. THE PT REPORTED THE SYMPTOM OF THE LOSS OF PERMANENT TOOTH (2.2 - UPPER LEFT LATERAL INCISOR). THE TREATING DR INDICATED THAT A CLASS III TOOTH MOBILITY WAS REPORTED PRIOR TO THE TOOTH LOSS. THE PT DID NOT REPORT ANY TOOTH MOVEMENT OF TOOTH 2.2 AT ALIGNER STAGE #7, BEFORE THE TOOTH CAME OUT. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INC INVISALIGN FULL 96377944

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other