BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTM CLEAR ALIGNER

    MDR report key: 4939621 · Received July 22, 2015

    Report

    Report Number
    3009683512-2015-00006
    Event Type
    Injury
    Date Received
    July 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE ALIGNER WAS RETURNED, AN OVERLAY WAS DONE ON THE NEW IMPRESSION RECEIVED FOR MID-COURSE CORRECTION AND THE FINAL MODEL FROM THE TREATED CASE. IT APPEARS THAT TWO INTERMEDIATE ALIGNERS WERE NOT USED THEREFORE, THE ALIGNER USED WAS INAPPROPRIATE FOR THE PT AT THAT TIME. HOWEVER, BECAUSE INTERVENTION WAS REQUIRED TO REMOVE THE ALIGNER, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT A DENTIST REPORTED THAT ALTHOUGH A PT HAD NO FIT ISSUES WITH ALL PRIOR MTM ALIGNERS (TOP AND BOTTOM), THE FINAL LOWER UN-ACTIVATED ALIGNER FIT VERY SNUGLY INTO PLACE. FURTHERMORE, WHEN THE PT WENT TO REMOVE THE ALIGNER SHE WAS UNABLE TO DO SO, BOTH BY HAND AND WITH RETAINER RETRIEVERS. THE PT MADE AN APPOINTMENT TO HAVE THE FINAL LOWER REMOVED WITH A DENTAL TOOL IN THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475686 MTM CLEAR ALIGNER SEQUENTIAL ALIGNER NXC RAINTREE ESSIX INC. 6794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention