BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESMILE RETAINER

    MDR report key: 19831183 · Received July 25, 2024

    Report

    Report Number
    1649995-2024-00020
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 17, 2024
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR EVALUATION: WE REVIEWED THE DHR FOR SO-155SO1432719 / PATIENT ID# (B)(6) / PRACTICE ID# (B)(6), QTY. (B)(4) ASSY-500015 (RETAINER) WERE PACKAGED BY THE THIRD SHIFT BY AUTO BAG AND BOX OPERATION ON (B)(6) 2024, MANUFACTURING SUPERCELL 1, EQUIPMENT PUA-07. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. PHOTO INVESTIGATION: THE EVIDENCE PROVIDED BY THE CUSTOMER SHOWS TWO RETAINERS, A LOWER RETAINER AND AN UPPER RETAINER, WITH A CRACK IN THE LEFT CENTRAL INCISOR. THE EVIDENCE IS NOT CLEAR ENOUGH TO IDENTIFY THE ISSUE OF THE ALLEGED EVENT (SHARP EDGES). THE DESCRIPTION OF THE ALLEGED EVENT MENTIONS THAT THE CUSTOMER REMOVED THE SHARP POINT, BUT THE EVIDENCE DOES NOT SHOW THIS. THE EVIDENCE DOES NOT SHOW TRACEABILITY INFORMATION TO IDENTIFY THE DEVICE'S SERIAL NUMBER OR PATIENT ID. FAILURE MODE - SHARP EDGES. ROOT CAUSE - NO DEFECT - NO DEFECT DURING THE MANUFACTURING PROCESS. CONCLUSION CODE - NO FAILURE FOUND.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT WEARING SURESMILE RETAINER EXPERIENCED SHARP EDGES ON BOTH ALIGNERS DURING USE IN TREATMENT. PATIENT EXPERIENCED CUTTING AND PAIN. DENTIST REMOVED THE SHARP EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186928 SURESMILE RETAINER ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 22263855 00856379007269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown