BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER - SINGLE ARCH

    MDR report key: 5901423 · Received August 24, 2016

    Report

    Report Number
    1036212-2016-00011
    Event Type
    Injury
    Date Received
    August 24, 2016
    Report Date
    July 25, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS EVENT MAY RESULT 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 IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPPER #2 ALIGNER WAS RETURNED BUT COMPLAINT NOTED THAT THE ISSUE OCCURRED WHEN USING THE #3 ALIGNER. A REQUEST WAS SENT TO THE DOCTOR FOR RETURN OF THE #3 ALIGNER. REVIEW OF THE #2 DONE TO SEE IF THERE WAS ANYTHING THAT COULD HELP WITH THIS INVESTIGATION. THE ACTIVATION IN THE #2 MATCHES THE ORIGINAL TREATMENT PLAN FROM CASE (B)(4), NOT THE REFINEMENT CASE (B)(4) THAT THE COMPLAINT WAS INITIATED IN REFERENCE TO. THIS ALIGNER WILL NOT ASSIST IN DETERMINING A ROOT CAUSE OF THE ISSUE FOR THIS PATIENT. HOWEVER, IT HAS RAISED THE QUESTION OF WHICH ALIGNER #3 WAS IN USE WHEN THE PATIENT EXPERIENCED THE ISSUE (#3 FROM THE ORIGINAL CASE MATERIALS OR #3 FROM THE REFINEMENT CASE MATERIALS). A MESSAGE WAS SENT TO THE DOCTOR TO REQUEST CONFIRMATION OF WHICH #3 ALIGNER WAS IN USE AT THE TIME OF THE ISSUE. AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    A CLINICIAN REPORTED THAT DURING REFINEMENT OF MTM ALIGNER THERAPY, IT WAS PROGRESSING AS SHOWN BY THE TREATMENT PLAN UNTIL THE PATIENT INSERTED THE THIRD UPPER ALIGNER. AFTER SEATING THE THIRD UPPER ALIGNER, THE PATIENT HEARD A "CRACK" AND BEGAN TO EXPERIENCE PAIN IN A TOOTH. THE PATIENT WAS INSTRUCTED TO DISCONTINUE USE OF THE ALIGNERS. X-RAYS OF THE ROOT IN QUESTION DID NOT INDICATE TRAUMA TO THE ROOT. AN ENDODONTIST WILL BE PERFORMING AN IN OFFICE EXAM ON THE PATIENT. ADDITIONAL INFORMATION REGARDING THAT EXAM IS NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554376 MTML-CLEAR ALIGNER - SINGLE ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 12143-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other