BEUDAMED
    FDA Adverse Event Other Summary report: N

    INION CPS BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 558719 · Received December 9, 2004

    Report

    Report Number
    9710629-2004-00009
    Event Type
    Other
    Date Received
    December 9, 2004
    Date of Event
    April 22, 2004
    Report Date
    December 2, 2004
    Manufacturer
    INION LTD.
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADVANCEMENT SAGITTAL SPLIT OSTEOTOMY 3/2003. 6 MONTHS POSTOPERATIVELY LEFT PLATE DEHISCENSE WITH GRANULATION TISSUE. GRANULATION TISSUE DEBRIDED. ONE YEAR POSTOPERATIVELY SCREW AND PLATE FRAGMENTS AT BONE SURFACE. BONE HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE FIXATION SYSTEM BONE PLATE JEY INION LTD. PLT-1023 NK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other