BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-SINGLE ARCH

    MDR report key: 5923684 · Received September 1, 2016

    Report

    Report Number
    1036212-2016-00012
    Event Type
    Injury
    Date Received
    September 1, 2016
    Report Date
    August 5, 2016
    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

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN WEARING MTM ALIGNERS AND IT APPEARS AS THOUGH TOOTH #25 BECAME INTRUDED. THE DENTIST ALSO STATED THAT THE #4 ALIGNER DIDN'T FIT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574158 MTML-CLEAR ALIGNER-SINGLE ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 16194-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other