BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 19330462 · Received May 16, 2024

    Report

    Report Number
    1649995-2024-00014
    Event Type
    Injury
    Date Received
    May 16, 2024
    Report Date
    August 13, 2024
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 RESULTS: DHR EVALUATION: WE REVIEWED THE DHR FOR THIS (B)(6) / PATIENT ID# (B)(6) / PRACTICE ID# (B)(4) QTY. (B)(4) (ALIGNERS), AND (B)(4) (TEMPLATE), WERE PACKAGED BY THE SECOND SHIFT BY BAG AND BOX OPERATION ON (B)(6) 2023, MANUFACTURING SUPERCELL SC0, EQUIPMENT BAG-12. 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 USED TO MANUFACTURE THIS (B)(6). · RAW MATERIAL: PART-501019 / LOT# 233734 / QTY. RECEIVED = (B)(4), INSPECTION DATE: (B)(6), 2023. · THE MATERIAL WAS FOUND TO BE ACCEPTABLE FOR USE IN THE MANUFACTURE OF THE SURE SMILE PRODUCT. FAILURE MODE: ALLERGIC REACTION. ROOT CAUSE: NO DEFECT - NO DEFECT DURING MANUFACTURING PROCESS CONCLUSION CODE: NO FAILURE FOUND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PATIENT HAD ALLERGIC REACTION TO THE USE OF NONTEMPLATE ALIGNER ARCH. THEIR SYMPTOMS INCLUDED MIGRAINES, BLURRED VISION, PAIN TO THE POINT WHERE IT WAS UNCOMFORTABLE TO WEAR THEIR ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474328 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown