BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 20301850 · Received September 25, 2024

    Report

    Report Number
    1649995-2024-00034
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Report Date
    December 9, 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
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE REVIEWED THE DHR FOR THIS (B)(6) / PATIENT ID#: (B)(6) / PRACTICE ID#: (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND (B)(4) ITEMS ASSY-500010 (TEMPLATE) WERE PACKAGED BY THE SECOND SHIFT BY BAG-AND-BOX OPERATION ON AUGUST 24, 2024, MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-06. THE SALES ORDER WAS INSPECTED AND MET WITH THE ACCEPTANCE CRITERIA PROVIDED BY QA. PHOTO INVESTIGATION. THE PROVIDED EVIDENCE SHOWS APPARENT IRRITATION ON THE PATIENT'S LIP, BUT IT IS NOT POSSIBLE TO IDENTIFY THE AREA OF THE POTENTIAL INJURY. THE DEVICES (ALIGNERS) USED BY THIS PATIENT ARE NOT SHOWN TO IDENTIFY ANY POTENTIAL MANUFACTURING DEFECTS OF THE DEVICES.

    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 SERIAL/LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT NONTEMPLATE ALIGNER ARCH ALIGNERS SEEM TO HAVE SHARP AND ROUGH EDGES THAT IS CAUSING IRRITATION/CUTTING OF THE PATIENT'S LIPS. PATIENT DISPOSED OF THE ALIGNERS; THEY WILL NOT BE RETURNED. PHOTO PROVIDED CONFIRMS IRRITATION/CUTTING, NO ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199197 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown