BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM

    MDR report key: 25121643 · Received May 8, 2026

    Report

    Report Number
    0001038806-2026-02542
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019560
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NECK OF THE IMPLANT AT TOOTH SITE 46 FRACTURED. IMPLANT WAS REMOVED WITH AN IMPLANT REMOVAL TOOL. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222014 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 63203104 00889024019560

    Patients

    Seq Age Sex Outcome Treatment
    1