BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 15581893 · Received October 11, 2022

    Report

    Report Number
    0002023141-2022-02547
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    August 25, 2021
    Report Date
    October 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). ADDITIONAL PMA/510(K) NUMBERS ARE K011028 AND K013227.

    Description of Event or Problem · 0

    DOCTOR INDICATED IMPOSSIBLE TO REMOVE THE MOUNT FROM THE IMPLANT. NEW IMPLANT WAS PLACED. TOOTH SITE # 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483214 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1244535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male