BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 21077895 · Received January 6, 2025

    Report

    Report Number
    1649995-2025-00001
    Event Type
    Injury
    Date Received
    January 6, 2025
    Report Date
    April 1, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT/SERIAL NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE PATIENT DEVELOPED A POSTERIOR OPEN BITE AFTER USING ALIGNERS DUE TO PREMATURE ANTERIOR CONTACTS. IN THE LAST PLAN THAT WAS SENT, THOSE CONTACTS WERE REMOVED, AND AN AUTOROTATION WAS PERFORMED. THE INITIAL LOWER CROWDING WAS VERY SEVERE AND PRESENTED A CROSSBITE, WHICH HAS NOW BEEN FULLY CORRECTED. I BELIEVE THAT BY CREATING MORE OVERJET IN A NEW PLAN, THE POSTERIOR OPEN BITE CAN BE CORRECTED. DHR: WE REVIEWED THE DHR FOR THIS SO-SR02224843 / PATIENT ID# (B)(6) / SITE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND 2 ITEMS ASSY-500010 (TEMPLATES), WERE PACKAGED BY THE FIRST SHIFT BY BAG-AND-BOX OPERATION ON (B)(6) 2022, MANUFACTURING CELL 4, EQUIPMENT BAG-12. THE SALES ORDER WAS INSPECTED AND MET WITH THE ACCEPTANCE CRITERIA PROVIDED BY QA. FAILURE MODE - UNINTENDED MOVEMENT/OPEN BITE. ROOT CAUSE - NO DEFECT DURING THE MANUFACTURING PROCESS. CONCLUSION CODE - NO FAILURE FOUND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A THAT HAS BEEN IN TREATMENT USING NONTEMPLATE ALIGNER ARCH - SURESMILE - SINCE 2022 HAS A POSTERIOR OPEN BITE. EACH REFINEMENT SUBMITTED HAD NO CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351239 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown