BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESMILE RETAINER

    MDR report key: 20784047 · Received November 26, 2024

    Report

    Report Number
    1649995-2024-00054
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Report Date
    January 31, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    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/SERIAL 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

    DHR: WE REVIEWED THE DHR FOR (B)(6) / PATIENT ID#: (B)(6) / SITE ID#: 05700, QTY. (B)(4) ITEMS ASSY-500015 (RETAINERS) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON NOVEMBER 08, 2024, MANUFACTURING SUPERCELL SC2, EQUIPMENT PUA-03. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. PHOTO INVESTIGATION: THE EVIDENCE PROVIDED BY THE CUSTOMER (PHOTO) SHOWS AN APPARENT RETAINER; THE IMAGE IS NOT CLEAR ENOUGH TO IDENTIFY THE ISSUE OF THE ALLEGED EVENT. THE TRACEABILITY INFORMATION (SERIAL NUMBER, PATIENT ID) IS NOT VISIBLE FOR DEVICE IDENTIFICATION.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT WEARING SURE SMILE RETAINER EXPERIENCED THE ALIGNERS HAVING ROUGH/SHARP EDGES ON ALL RETAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404031 SURESMILE RETAINER ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown