BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESMILE RETAINER

    MDR report key: 22723225 · Received August 5, 2025

    Report

    Report Number
    1649995-2025-00054
    Event Type
    Injury
    Date Received
    August 5, 2025
    Report Date
    October 29, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    KMY
    UDI-DI
    00856379007269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OTHER. DL PROTOCOL WAS FOLLOWED. SCANS AND DIGITAL MODELS LOOK GOOD. DHR: WE REVIEWED THE DHR FOR THIS SO- (B)(6)/ PATIENT ID# (B)(6) / SITE ID# (B)(6), QTY. (B)(4) ITEMS ASSY-500015 (RETAINERS) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON JULY 14, 2025, IN MANUFACTURING SUPERCELL SC3, EQUIPMENT PUA-10. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. RETURN: WE RECEIVED THE RETURN OF 2 RETAINERS, PATIENT ID: (B)(6). WE INSPECTED THE RETURNED RETAINER (URET SN: (B)(6) AND LRET SN: (B)(6)) AND FOUND NO DEFORMATIONS OR DISTORTIONS IN THE DEVICE TRAYS THAT COULD CAUSE THE ISSUE DESCRIBED IN THE REPORTED EVENT. THE RETAINERS MEET THE QUALITY CRITERIA SPECIFIED IN 0281-WI-ALN-005-3 FINAL QUALITY CONTROL AND ALIGNER WASHING, VISUAL DEFECT DETECTION.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT DURING USE OF SURESMILE RETAINER, THE RETAINER WAS TOO TIGHT TO REMOVE. WHEN IT WAS ATTEMPTED TO REMOVE IT CAUSED CHIPPING ON A RESTORATION OF A TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555833 SURESMILE RETAINER POSITIONER, TOOTH, PREFORMED KMY DENTSPLY SIRONA ORTHODONTICS INC. 00856379007269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability