BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 20723799 · Received November 19, 2024

    Report

    Report Number
    1649995-2024-00050
    Event Type
    Injury
    Date Received
    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
    WY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WE REVIEWED THE DHR FOR (B)(6) / PATIENT ID# (B)(6) / SITE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND 2 ITEMS ASSY-500010 (TEMPLATE) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON (B)(6) 2024, MANUFACTURING SUPERCELL SC1, EQUIPMENT PUA-07. THE SALES ORDER WAS INSPECTED AND MET WITH 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 TO BE ACCEPTABLE FOR USE IN THE MANUFACTURE OF THE SURE SMILE PRODUCT. PHOTO INVESTIGATION: THE EVIDENCE PROVIDED BY THE CUSTOMER (PHOTOS) SHOWS THE PATIENT'S FACE AND APPARENT SWELLING ON THE TONGUE. IN THE ALLERGY REACTION CHECKLIST, THE CUSTOMER MENTIONED THEY SUFFER FROM ALLERGIES TO CERTAIN FOODS (FISH/SHELLFISH), SOME MEDICATIONS (PERCOCET, MORPHINE, ALL PAIN MEDS, CT CONTRAST STEROIDS), AND ADHESIVE GLUE. THEY ALSO STATE THAT NO ALLERGY TESTS WERE CONDUCTED ON THE PATIENT FOR THE PRODUCT. THE PROVIDED EVIDENCE DOES NOT SHOW THE DEVICES (ALIGNERS) PLACED ON THE PATIENT. RETURN WE RECEIVED THE RETURN OF (B)(4) BOXES ((B)(4) ALIGNERS) FROM SALES ORDER (B)(6), PATIENT ID: (B)(6). WE FOUND THE PACKAGING BAG OF THE STAGE (B)(4) ALIGNERS TO BE OPEN. WE INSPECTED THE ALIGNERS AND DID NOT FIND ANY ANOMALIES IN THEIR DESIGN AND/OR SPECIFICATIONS.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PATIENT USING NONTEMPLATE ALIGNER ARCH EXPERIENCED ALLERGIC REACTION TO THE ALIGNERS. REQUESTED FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43162 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown