BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTM ALIGNER

    MDR report key: 6358524 · Received February 24, 2017

    Report

    Report Number
    1036212-2017-00001
    Event Type
    Injury
    Date Received
    February 24, 2017
    Report Date
    April 25, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE THE DEVICE MALFUNCTIONED AND THAT MALFUNCTION RESULTED IN A SERIOUS INJURY, 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. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN WEARING MTM ALIGNERS AND TOOTH #8 AND #9 BECAME INTRUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140895 MTM ALIGNER ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 16268

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention