BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 6811337 · Received August 22, 2017

    Report

    Report Number
    1036212-2017-00005
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    September 21, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K163155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 1

    BECAUSE A SERIOUS INJURY RESULTED IN THIS EVENT, IT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING TREATMENT WITH MTM CLEAR ALIGNER. THE DOCTOR SAW THE PATIENT ON (B)(6) 2017 TO SEAT THE #3 UPPER AND LOWER ALIGNERS. THE DOCTOR STATED SOMETIME BEFORE THE END OF (B)(6) THE PATIENT INCURRED A CUT ON HER INSIDE UPPER LIP FROM A SHARP EDGE OF THE #3 UPPER ALIGNER. HE FEELS THAT WAS DUE TO THE PATIENT'S MOBILITY ISSUES. THE PATIENT DID NOT CONTACT THE DOCTOR OR RETURN FOR THE ALIGNER TO BE POLISHED DOWN. THE CUT BECAME AN OPEN WOUND THAT WAS SWOLLEN AND INCURRED AN E. COLI INFECTION THAT ENTERED HER BLOODSTREAM. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. THE DOCTOR STATED THAT AT THIS POINT, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592353 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 20111

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R