BEUDAMED
    FDA Adverse Event Other Summary report: N

    INION CPS BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 633468 · Received September 6, 2005

    Report

    Report Number
    9710629-2005-00007
    Event Type
    Other
    Date Received
    September 6, 2005
    Date of Event
    August 3, 2005
    Report Date
    August 31, 2005
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BSSO/GENIOPLASTY. TWO WEEKS POSTOPERATIVE SCREWS WERE FOUND TO BE BROKEN. REOPERATION WITH TITANIUM IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE FIXATION SYSTEM BONE FIXATION FASTENER HWC INION LTD. SCR-1216 LOT03100054

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other