BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSIII SA

    MDR report key: 17856424 · Received October 2, 2023

    Report

    Report Number
    3003394081-2023-00004
    Event Type
    Injury
    Date Received
    October 2, 2023
    Report Date
    April 6, 2023
    Manufacturer
    OSSTEM IMPLANT CO., LTD.
    Product Code
    DZE
    PMA / PMN Number
    K161604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DENTAL IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971051 TSIII SA DENTAL IMPLANT DZE OSSTEM IMPLANT CO., LTD. BTS3S4010S FTP21J155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention