BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 21409722 · Received February 19, 2025

    Report

    Report Number
    1649995-2025-00007
    Event Type
    Injury
    Date Received
    February 19, 2025
    Report Date
    February 19, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE 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 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 · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT NOW HAS AN ANTERIOR OPEN BITE WITH THE USE OF NONTEMPLATE ALIGNER ARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571246 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown