BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMETAPER EV Ø4.8 X 11MM OS

    MDR report key: 24766085 · Received April 2, 2026

    Report

    Report Number
    9612468-2026-01617
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 2, 2026
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    UDI-DI
    07392532276798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 IMPLANT LOSS. SF- (B)(4). MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828863 PRIMETAPER EV Ø4.8 X 11MM OS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 474149 07392532276798

    Patients

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