BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 6994694 · Received November 1, 2017

    Report

    Report Number
    1036212-2017-00009
    Event Type
    Injury
    Date Received
    November 1, 2017
    Report Date
    February 7, 2018
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K163155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE TREATMENT MAY NOT HAVE CAUSED THE ROOT RESORPTION, IT COULD POSSIBLY HAVE CONTRIBUTED TO IT. THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERGOING TREATMENT WITH MTM ALIGNERS EXPERIENCED ROOT RESORPTION ON TOOTH #9 AND MAY LOSE THE TOOTH. THE DENTIST ALSO STATED "MAYBE YOU CAN SEE ROOT RESORPTION A LITTLE ON THE PANORAMIC (X-RAY), PRIOR TO MTM TREATMENT" AND THAT THE PATIENT ADMITTED TO A POSSIBLE CHILDHOOD TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774553 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability