BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS BIOABSORBABLE PLATING SYSTEM

    MDR report key: 553562 · Received November 1, 2004

    Report

    Report Number
    3003547707-2004-00004
    Event Type
    Injury
    Date Received
    November 1, 2004
    Date of Event
    April 16, 2004
    Report Date
    October 27, 2004
    Manufacturer
    INION LTD.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MAXILLARY HYPOPLASIA WITH LE FORT I OSTEOTOMY. AFTER TWO WEEKS MAXILLA WAS FOUND TO BE MOBILE. SCREWS WERE FRACTURED ON THE LEFT. REOPERATION WITH TITANIUM PLATES AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE PLATING SYSTEM BONE FIXATION FASTENER HRS INION LTD. SCR 1224 0206025

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention