BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-SINGLE ARCH

    MDR report key: 5851966 · Received August 5, 2016

    Report

    Report Number
    1036212-2016-00010
    Event Type
    Injury
    Date Received
    August 5, 2016
    Report Date
    July 8, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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 IT APPEARS AS THOUGH TOOTH #9 BECAME EXTRUDED. THE DENTIST ALSO STATED THAT THE #4 ALIGNER, WHICH THE PATIENT WAS STILL WEARING, NEVER SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502958 MTML-CLEAR ALIGNER-SINGLE ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 14781

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention