BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE SYSTEM

    MDR report key: 511609 · Received December 15, 2003

    Report

    Report Number
    9710629-2003-00001
    Event Type
    Malfunction
    Date Received
    December 15, 2003
    Date of Event
    March 3, 2003
    Report Date
    December 15, 2003
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE SYSTEM BONE FIXATION FASTENER HWC INION LTD. SCR-1214 0202027

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention