BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 24949793 · Received April 22, 2026

    Report

    Report Number
    0001038806-2026-02188
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO A FRACTURE OF THE IMPLANT MOUNT INSIDE THE IMPLANT. NO IMPACT ON THE PATIENT REPORTED. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535086 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1301555 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1