BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE SYSTEM

    MDR report key: 511585 · Received January 20, 2004

    Report

    Report Number
    9710629-2003-00003
    Event Type
    Malfunction
    Date Received
    January 20, 2004
    Report Date
    December 15, 2003
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALIGNMENT OF TEETH/JAW PERFECT AFTER THE SURGERY. GUIDING ELASTICS WERE APPLIED. 1-DAY POSTOP ALIGNMENT OF TEETH/JAWS WAS NOTICED TO BE CHANGED. 5-WEEKS POST-OP X-RAYS SHOWED THAT THE PROXIMAL FRAGMENTS HAD ROTATED UPWARD. AT REOPERATION SCREWS WERE DETECTED TO BE BROKEN AND WERE REPLACED WITH STAINLESS STEEL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE SYSTEM BONE FIXATION FASTENER HWC INION LTD. SCR-1215 0202027

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention