BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL.DRIVER P EV 4.2 LONG

    MDR report key: 24220112 · Received January 30, 2026

    Report

    Report Number
    3013111692-2026-04221
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Report Date
    January 30, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NDP
    UDI-DI
    07392532144073
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. PRODUCTS 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 THAT A PATIENT EXPERIENCED A TOOL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284480 IMPL.DRIVER P EV 4.2 LONG ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS MANUFACTURING GMBH 200050367 07392532144073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention