BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 6896911 · Received September 27, 2017

    Report

    Report Number
    1036212-2017-00007
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    August 28, 2017
    Report Date
    November 20, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K163155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    THEREFORE, BECAUSE THIS EVENT RESULTED IN A SERIOUS INJURY, 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 UNDERGOING TREATMENT WITH MTM ALIGNERS EXPERIENCED HEMORRHAGING AND BLEEDING IN TOOTH #9 WHILE WEARING HER FINAL ALIGNER. TOOTH #9 HAS BEEN EXTRACTED AS A RESULT. THE PATIENT HAD HER FINAL UPPER TRAY (TRAY 5) INSERTED ON (B)(6) 2017. ABOUT A WEEK AFTER INSERTION, SHE NOTICED A DISCOLORATION OF TOOTH #9. OVER THE NEXT WEEK, THE TOOTH BECAME PAINFUL. THE PATIENT WAS SEEN AT HER DENTIST OFFICE ON (B)(6) 2017. THE PATIENT HAD AN INCOMPLETE ROOT CANAL PERFORMED AT THAT TIME WITH PLANS TO EXTRACT THE TOOTH AND EVENTUALLY REPLACE IT WITH AN IMPLANT. ON (B)(6) 2017, THE PATIENT HAD THE TOOTH EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676275 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 22596

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability