BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS BABY BIODEGRADABLE SYSTEM

    MDR report key: 532862 · Received June 30, 2004

    Report

    Report Number
    9710629-2004-00003
    Event Type
    Injury
    Date Received
    June 30, 2004
    Date of Event
    June 4, 2004
    Report Date
    June 29, 2004
    Manufacturer
    INION LTD.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FRONTO-ORBITAL ADVANCEMENT (BANDEAU) WITH FRONTAL CRANIOPLASTY AND EXPANSION. THREE DAY POST OP HEMATOMA REQUIRING EVACUATION. FINDING AT RE-OPERATION: BUCKLING OF TWO PLATES SPANNING FRONTO-PARIETAL OSTEOTOMY GAP FROM FRONTAL ADVANCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BABY BIODEGRADABLE SYSTEM BONE PLATE HRS INION LTD. PLT-1029 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention