BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 20770789 · Received November 25, 2024

    Report

    Report Number
    1649995-2024-00051
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 31, 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
    AS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT 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

    WE REVIEWED THE DHR FOR (B)(6) / PATIENT ID#(B)(6) / SITE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND 2 ASSY-500010 (TEMPLATE) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON (B)(6) 2024, MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-03. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. INCOMING INSPECTION. WE REVIEWED THE INCOMING INSPECTION RECORD FOR THE MATERIAL MANUFACTURING THIS (B)(6). ¿ RAW MATERIAL: PART-501019 / LOT# 233744 / QTY. RECEIVED = (B)(4), INSPECTION DATE: (B)(6) 2024. ¿ THE MATERIAL WAS FOUND ACCEPTABLE FOR USE IN THE SURESMILE PRODUCT'S MANUFACTURE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD COMPLAINTS OF HAVING SORE THROAT SINCE STARTING TREATMENT WITH NONTEMPLATE ALIGNER ARCH. UNKNOWN IF IT COULD BE ALLERGIC REACTION TO ALIGNERS, BUT PATIENT DOES NOT THINK SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707400 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 09318743 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown