BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE FIXATION

    MDR report key: 892435 · Received August 13, 2004

    Report

    Report Number
    9710629-2004-00002
    Event Type
    Malfunction
    Date Received
    August 13, 2004
    Date of Event
    August 20, 2003
    Report Date
    April 13, 2004
    Manufacturer
    INION, LTD.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE FIXATION BONE FIXATION FASTENER MAI INION, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention