BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT DRIVER EV (S) SHORT

    MDR report key: 24933240 · Received April 20, 2026

    Report

    Report Number
    9612468-2026-02020
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 20, 2026
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    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 PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED. AS PER ATTACHED EMAIL: THE METAL DRIVER IS 25379*1 , THE COMPLAINT REASON INPUT IN CF ADDITION INFORMATION/ DISCERPTION , THAT IS ABRASION & CAN NOT STUCK THE IMPLANT, OTHER TOOLS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988209 IMPLANT DRIVER EV (S) SHORT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown