BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 20629036 · Received November 7, 2024

    Report

    Report Number
    1649995-2024-00044
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 24, 2024
    Report Date
    January 7, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, 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: WE REVIEWED THE DHR FOR (B)(6) / PATIENT ID#: (B)(6) / PRACTICE ID#: (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND 2 ITEMS ASSY-500010 (TEMPLATES) WERE PACKAGED BY THE FIRST SHIFT IN AN AUTO BAG-AND-BOX OPERATION ON (B)(6) 2024, MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-06. PHOTO INVESTIGATION: THE PROVIDED EVIDENCE (PHOTO) SHOWS A LOWER ALIGNER L2 FROM PATIENT (B)(6). SOME PHOTOS SHOW THE ALLEGED EVENT ISSUE (SHARP EDGES); HOWEVER, NOT ALL THE PHOTOS ARE CLEAR ENOUGH TO IDENTIFY THE ISSUE IN ALL OF THEM. FAILURE MODE - SHARP EDGES. ROOT CAUSES - OPERATOR ERROR. CONCLUSION CODE - PRODUCT FAILURE - MANUFACTURING.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT THE ALIGNERS - NONTEMPLATE ALIGNER ARCH - ARE SHARP EDGED, NOT ROUNDED OR POLISHED ON BOTH UPPER AND LOWER. THE DOCTOR HAS MANUALLY REWORKED THE ALIGNERS TO PREVENT INJURY TO THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49080 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 09346638 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown