BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTM CLEAR ALIGNER

    MDR report key: 6472557 · Received April 7, 2017

    Report

    Report Number
    1036212-2017-00002
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    April 7, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT A LAB PRODUCTION ISSUE WAS NOT ADDRESSED DURING CASE PROCESSING. DUE TO THE ERROR, THERE WAS UNINTENDED TOOTH MOVEMENT. 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 DURING TREATMENT ON A PATIENT WITH MTM ALIGNERS, UNINTENDED MOVEMENT OCCURRED ON TOOTH #8. THE TOOTH BECAME CANTED AND TURNED INSTEAD OF BEING VERTICALLY EVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255554 MTM CLEAR ALIGNER ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 17689-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention