BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMETAPER EV Ø3.6 X 17MM OS

    MDR report key: 24279761 · Received February 6, 2026

    Report

    Report Number
    9612468-2026-00657
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 6, 2026
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    UDI-DI
    07392532276682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 0

    CUSTOMER REPORTED LOOSENING ISSUE IMPLANT LOSS SF - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343915 PRIMETAPER EV Ø3.6 X 17MM OS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 520590 07392532276682

    Patients

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