BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE PLATING SYSTEM

    MDR report key: 585866 · Received March 22, 2005

    Report

    Report Number
    3003547707-2005-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2005
    Date of Event
    February 22, 2005
    Report Date
    March 17, 2005
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCREW FRACTURE POSTOPERATIVELY, REOPERATION WITH TITANIUM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE PLATING SYSTEM SCREW HWC INION LTD. SCR 1290 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other