BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSCAN BODY COMPATIBLE WITH HIOSSEN (OSSTEM) ET (TS) REGULAR

    MDR report key: 21307013 · Received February 4, 2025

    Report

    Report Number
    3012422693-2025-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    March 7, 2023
    Report Date
    February 4, 2025
    Manufacturer
    TRUABUTMENT KOREA CO., LTD.
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE ABUTMENT DID NOT FIR PROPERLY. THE ABUTMENT CONNECTION WAS ROTATED OWING TO SCANBODY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52629 TRUSCAN BODY COMPATIBLE WITH HIOSSEN (OSSTEM) ET (TS) REGULAR SCAN BODY NDP TRUABUTMENT KOREA CO., LTD. OTR-SB KCCBA1101074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose