BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL.DRIVER P EV 4.8 SHORT

    MDR report key: 23985726 · Received January 6, 2026

    Report

    Report Number
    3013111692-2026-00704
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Report Date
    January 6, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. PRODUCT RETURN IS REQUESTED AND 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

    IT WAS REPORTED AN IMPLANT DRIVER BROKE WHILE PLACING IMPLANT; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39089 IMPL.DRIVER P EV 4.8 SHORT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS MANUFACTURING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT PROVIDED