BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBYTE VIBRATION DEVICE

    MDR report key: 24535722 · Received March 6, 2026

    Report

    Report Number
    2424472-2026-00596
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    DENTSPLY LLC
    Product Code
    OYH
    UDI-DI
    D001V181151
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. CUSTOMER COMPLAINTS ARE REVIEWED DURING MONTHLY PSC MEETINGS. THE FAILURE MODE MENTIONED IN THIS COMPLAINT IS ALSO IDENTIFIED AS A POTENTIAL HAZARD IN THE CORRESPONDING RISK MANAGEMENT FILE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. EVALUATION OF DEVICE IS NOT WARRANTED FOR INDIVIDUAL ADVERSE EFFECT OR SENSITIVITY TO DEVICE USAGE. THE LOT NUMBER INFORMATION REQUIRED FOR A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PROVIDED. THE USER WAS INSTRUCTED TO IMMEDIATELY DISCONTINUE USE OF THE PRODUCT. FAILURE MODE - TMJ/LOCKJAW ROOT CAUSE - PATIENTS CONDITION CONCLUSION CODE - EVENT CAUSED BY PATIENT CONDITIONS/FACTORS

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A HYPERBYTE VIBRATION DEVICE USED BY A PATIENT CAUSED THEIR JAW TO LOCK. THEY STOPPED USE OF THE DEVICE DUE TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315755 HYPERBYTE VIBRATION DEVICE ORTHODONTIC VIBRATORY ACCESSORY OYH DENTSPLY LLC D001V181151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female