BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT EQUATOR METAL HOUSING

    MDR report key: 24873752 · Received April 14, 2026

    Report

    Report Number
    3004203816-2026-09928
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    EGG
    UDI-DI
    07290109007427
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. PRODUCTS RETURN IS REQUESTED AND THEY WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PRODUCT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150959 OT EQUATOR METAL HOUSING ATTACHMENT, PRECISION, ALL EGG MIS IMPLANTS TECHNOLOGIES LTD. W24017792 07290109007427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention NOT PROVIDED