BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSCAN BODY COMPATIBLE WITH BIOHORIZONS INTERNAL 5.7

    MDR report key: 17509732 · Received August 10, 2023

    Report

    Report Number
    MW5122988
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    February 22, 2023
    Report Date
    August 8, 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
    *

    Narratives

    Description of Event or Problem · 0

    THE ABUTMENT CONNECTION WAS ROTATED. SAME LOT# PRODUCTS ARE FINE. AS A RESULT OF THE QUALITY TEST, IT WAS CONFIRMED THAT THE CONNECTION (HEX) OF THE BH57-SB SCANBODY AND THE DIRECTION OF THE D-CUT OF THE CAP WERE DISTORTED BY ABOUT 14°. HOWEVER, WHEN SEPARATING THE SCANBODY, THE COMPONENT BODY (BH57-SBB) WAS CONFIRMED AS A GOOD PRODUCT (NORMAL PRODUCT) WITHOUT HEX DISTORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084149 TRUSCAN BODY COMPATIBLE WITH BIOHORIZONS INTERNAL 5.7 ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP TRUABUTMENT KOREA CO.,LTD. BH57-SB KCCBB0927043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown