BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE SYSTEM

    MDR report key: 430332 · Received November 14, 2002

    Report

    Report Number
    9710629-2002-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2002
    Date of Event
    October 9, 2002
    Report Date
    November 13, 2002
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIMAXILLARY SAGITTAL SPLIT OPERATION (BSSO). THE OSTEOTOMIES WERE PERFORMED AND THE PATIENT WAS PLACED IN "MMF". THREE 2.8 X 18MM SCREWS WERE PLACED EACH SIDE. TWO WEEKS POST-OP, THE PATIENT RETURNED FOR FOLLOW-UP. X-RAYS WERE TAKEN AND IT WAS CLEAR THAT THE BONE HAD SHIFTED. RE-OPERATION WAS DONE AND ALL SIX SCREWS WERE FOUND BROKEN AND WERE REPLACED WITH TITANIUM ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE SYSTEM BONE FIXATION FASTENER HWC INION LTD. SCR-1216 0202029

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention