BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 20303035 · Received September 25, 2024

    Report

    Report Number
    1649995-2024-00035
    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
    JA
    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

    WE REVIEWED THE DHR FOR THIS SO-(B)(6) / PATIENT ID# (B)(6) / SITE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND (B)(4) ITEMS ASSY-500010 (TEMPLATE) WERE PACKAGED BY THE SECOND SHIFT BY AUTO BAG-AND-BOX OPERATION ON JULY 25, 2024, MANUFACTURING SUPERCELL SC1, EQUIPMENT PUA-07. 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 HAD SHARP EDGES, WHICH REQUIRED ADDITIONAL WORK TO REMOVE DURING THE OPERATORY PROCESS. THIS INCREASED THE WORKLOAD, AND, ON THIS OCCASION, THE DENTIST REMOVED THE SHARP EDGES PRIOR TO PATIENT'S USAGE. TO PREVENT EXTRA WORK AT THE DENTIST'S SIDE, IT IS RECOMMENDED THAT ALL ALIGNERS BE PROPERLY FINISHED DURING THE MANUFACTURING PROCESS TO ENSURE NO SHARP EDGES REMAIN. THIS INCIDENT ASSOCIATED WITH PRODUCT MALFUNCTION. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264065 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown