BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM

    MDR report key: 8869155 · Received August 7, 2019

    Report

    Report Number
    0001038806-2019-00842
    Event Type
    Injury
    Date Received
    August 7, 2019
    Date of Event
    February 12, 2019
    Report Date
    August 7, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBERS: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH LOCATION 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665625 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 63940258

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention