BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESMILE RETAINER

    MDR report key: 20332299 · Received September 30, 2024

    Report

    Report Number
    1649995-2024-00036
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 23, 2024
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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: WE REVIEWED THE DHR FOR (B)(6) / PATIENT ID#: (B)(6) / PRACTICE ID#: (B)(4), QTY. (B)(4) ITEMS ASSY-500015 (RETAINERS) WERE PACKAGED BY THE FIRST SHIFT IN AN AUTO BAG-AND-BOX OPERATION ON SEPTEMBER 4, 2024, MANUFACTURING SUPERCELL SC1, EQUIPMENT PUA-07. PHOTO INVESTIGATION: THE PROVIDED EVIDENCE SHOWS A SET OF RETAINERS (URET SN: (B)(6) AND LRET SN: (B)(6) FOR PATIENT (B)(6). THE RETAINERS SHOW SPOTS WITH GREEN FILM RESIDUE ON THE CUSP OF THE PREMOLARS. THE AVAILABLE EVIDENCE DOES NOT CLEARLY SHOW ANY CONDITION RELATED TO SHARP EDGE ISSUES.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PATIENT WEARING SURESMILE RETAINER EXPERIENCED SHARP EDGES THAT CAUSED BRUISES, CUTS LINGUAL RETRACTION ON TEETH #29 AND #30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061138 SURESMILE RETAINER ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 09224657 00856379007269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown