BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 5684258 · Received May 27, 2016

    Report

    Report Number
    1036212-2016-00008
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE 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. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PATIENT WAS PLACED IN HER THIRD SET OF MTM ALIGNERS, SHE EXPERIENCED IMMEDIATE PAIN. THE PATIENT COULD ONLY WEAR THE ALIGNERS FOR APPROXIMATELY FOUR DAYS BEFORE SHE HAD TO TAKE THEM OUT BECAUSE SHE COULDN'T HANDLE THE PAIN ANY LONGER. THE PATIENT SAW HER DENTIST, WHO EXAMINED HER AND FOUND SHE HAD CRACKED A TOOTH. THE TOOTH NOW REQUIRES A CROWN. THE CLINICIAN DETERMINED THAT THERE WAS TOO MUCH TENSION IN THE ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340729 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 12505

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention