BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERBYTE VIBRATION DEVICE

    MDR report key: 22047107 · Received May 19, 2025

    Report

    Report Number
    2424472-2025-00222
    Event Type
    Injury
    Date Received
    May 19, 2025
    Report Date
    August 29, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    OYH
    UDI-DI
    D001V181151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR 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

    NO PRODUCT WILL BE RETURNED FOR THIS COMPLAINT AND NO DHR REVIEW COMPLETED BECAUSE PRODUCT LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A HYPERBYTE VIBRATION DEVICE AGGRAVATED THE PATIENT'S TMJ. THEY STOPPED USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158443 HYPERBYTE VIBRATION DEVICE ORTHODONTIC VIBRATORY ACCESSORY OYH DENTSPLY LLC N/A D001V181151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention