BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 21477642 · Received February 27, 2025

    Report

    Report Number
    1649995-2025-00011
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Report Date
    December 17, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    PMA / PMN Number
    K171860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS; DHR WE REVIEWED THE DHR FOR (B)(4) / PATIENT ID# (B)(6) / SITE ID# (B)(6), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND (B)(4) ITEMS ASSY-500010 (TEMPLATES) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON NOVEMBER 22, 2024, IN MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-03. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. FAILURE MODE - SHARP EDGES. ROOT CAUSE - NO DEFECT DURING THE MANUFACTURING PROCESS. CONCLUSION CODE - NO FAILURE FOUND.

    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 AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT NONTEMPLATE ALIGNER ARCH EDGE OF THE ALIGNER IS SHARP. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595667 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown