BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TS III SA

    MDR report key: 24588259 · Received March 13, 2026

    Report

    Report Number
    3003394081-2026-00002
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 13, 2026
    Manufacturer
    OSSTEM IMPLANT CO., LTD.
    Product Code
    DZE
    PMA / PMN Number
    K222778
    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
    658694 TS III SA DENTAL IMPLANT DZE OSSTEM IMPLANT CO., LTD. BTS3S4010S FTP18K145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention