BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE PLATING SYSTEM

    MDR report key: 608377 · Received May 23, 2005

    Report

    Report Number
    9710629-2005-00004
    Event Type
    Malfunction
    Date Received
    May 23, 2005
    Date of Event
    April 12, 2005
    Report Date
    May 17, 2005
    Manufacturer
    INION LTD.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIMAX OPERATION. IMF ELASTICS USED. POSTOPERATIVELY THE POSITION OF THE UPPER JAW WAS NOT OPTIMUM, HOWEVER THE PLATES WERE STILL IN PLACE WITH NO DETECTABLE CHANGES. REOPERATION WITH TITANIUM PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE PLATING SYSTEM BONE PLATE HRS INION LTD. 1040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other