BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER - DUAL ARCH FIRST REFINEMENT

    MDR report key: 7484186 · Received May 3, 2018

    Report

    Report Number
    1036212-2018-00001
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    May 3, 2018
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K163155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE ROOT CAUSE COULD BE DUE TO INCORRECT OCCLUSION OF THE UPPER AND LOWER MODELS RESULTING IN AN ALIGNMENT THAT COULD HAVE COMPROMISED THE BITE. SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING MTM ALIGNERS, DURING THE REFINEMENT STAGE A PATIENT BEGAN TO DEVELOP AN OPEN BITE. THE PATIENT WILL REQUIRE ANOTHER TYPE OF ORTHODONTIC APPLIANCE TO CORRECT THE OPEN BITE BECAUSE THE MTM ALIGNER PROCESS DOES NOT ALLOW FOR THIS TYPE OF CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326043 MTML-CLEAR ALIGNER - DUAL ARCH FIRST REFINEMENT ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 20028-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention