BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 18148058 · Received November 16, 2023

    Report

    Report Number
    1649995-2023-00046
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 25, 2023
    Report Date
    February 7, 2024
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR EVALUATION: WE REVIEWED THE DHR FOR THIS SO-SR03442441 / PATIENT ID# (B)(6)/ PRACTICE ID# 06398 QTY. 56 ITEMS ASSY-500011 (ALIGNERS), 02 ITEMS ASSY-500010 (TEMPLATES) WERE PACKAGED BY OF SECOND SHIFT BY AUTO PACKING OPERATION ON (B)(6) 2023, MANUFACTURING SUPERCELL SC1, EQUIPMENT PUA-08. THE SALES ORDER WAS INSPECTED AND MET WITH THE ACCEPTANCE CRITERIA PROVIDED BY QA. FAILURE MODE: ALLERGIC REACTION. ROOT CAUSE: NO DEFECT. CONCLUSION CODE: NO FAILURE FOUND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORT THAT PATIENT HAD ALLERGIC REACTION TO THE USE OF NONTEMPLATE ALIGNER ARCH. PATIENT REPORTEDLY COMPLAINED OF CHANGE IN THEIR TASTE ABILITY AND IS CONCERNED THAT IT IS RELATED TO REACTION TO THE WEARING OF THE ALIGNER. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080072 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 07169244 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male