BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17463540 · Received August 3, 2023

    Report

    Report Number
    MW5120608
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    February 21, 2023
    Report Date
    August 1, 2023
    Manufacturer
    TRUABUTMENT KOREA CO.,LTD
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE ABUTMENT DID NOT FIT PROPERLY. THE ABUTMENT CONNECTION WAS ROTATED OWING TO SCANBODY ISSUE. AS A RESULT OF THE QUALITY TEST, IT WAS CONFIRMED THAT THE CONNECTION (HEX) OF THE OTR-SB SCANBODY AND THE DIRECTION OF THE D-CUT OF THE CAP WAS ROTATED BY ABOUT 30°. WHEN SEPARATING THE SCANBODY, IT WAS VERIFIED THAT THE HEX POSITION OF THE COMPONENT BODY (OTR-SBB) WAS ALSO ROTATED (DISTORTED). THEREFORE, IT WAS CONFIRMED THAT THIS CASE WAS DEFECTIVE IN SHAPE DURING CNC MILLING, AND THAT IT WAS SHIPPED WITHOUT FILTERING THE DEFECT. DEFECT DURING MANUFACTURE: CONNECTION HEX ROTATED SAME LOT# PRODUCTS WERE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795952 TRUSCAN BODY COMPATIBLE WITH HIOSSEN (OSSTEM) ET (TS) REGULAR ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP TRUABUTMENT KOREA CO.,LTD OTR-SB KCCBA1101074

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose