BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMETAPER EV Ø3.6 X 11MM OS

    MDR report key: 25135681 · Received May 11, 2026

    Report

    Report Number
    9612468-2026-02378
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 11, 2026
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    UDI-DI
    07392532276651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. 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

    IT WAS REPORTED THAT THE IMPLANT TILTED MORE TOWARD THE LIP THAN PLANNED, CAUSING EXPOSURE OF THE IMPLANT BODY BEYOND THE BONE. THE IMPLANT WAS THEN LEFT FREE-STANDING, AND GBR (GUIDED BONE REGENERATION) WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489954 PRIMETAPER EV Ø3.6 X 11MM OS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 07392532276651

    Patients

    Seq Age Sex Outcome Treatment
    1