BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT DRIVER EV (L) LONG

    MDR report key: 24238732 · Received February 2, 2026

    Report

    Report Number
    9612468-2026-00590
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 2, 2026
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    NDP
    UDI-DI
    07392532254895
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. PRODUCT RETURN IS REQUESTED, AND PRODUCT 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

    CUSTOMER REPORTED TOOL ISSUE: "BROKEN DRIVER TIP". SF - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292055 IMPLANT DRIVER EV (L) LONG ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) N/A UNK 07392532254895

    Patients

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