BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 19949480 · Received August 9, 2024

    Report

    Report Number
    1649995-2024-00024
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 30, 2024
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR 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

    INVESTIGATION RESULTS: DHR EVALUATION: WE REVIEWED THE DHR FOR THIS (B)(6); PATIENT ID# (B)(6); PRACTICE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS), QTY. (B)(4) ITEMS ASSY-500010 (TEMPLATES), WAS PACKAGED BY THE SECOND SHIFT BY AUTO BAG AND BOX OPERATION ON (B)(6) 2024, MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-03. THE SALES ORDER WAS INSPECTED AND MET WITH THE ACCEPTANCE CRITERIA PROVIDED BY QA. FAILURE MODE - SHARP EDGES. ROOT CAUSE - NO DEFECT DURING THE MANUFACTURING PROCESS. CONCLUSION CODE - NO FAILURE FOUND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT NONTEMPLATE ALIGNER ARCH CAUSED IRRITATION AND CUTS TO THE PATIENT'S MOUTH FROM EDGES OF THE ALIGNERS THAT ARE SHARP. ADDITIONAL INFORMATION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205116 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 08726816 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female