BEUDAMED
    FDA Adverse Event Other Summary report: N

    INION CPS BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 619719 · Received June 29, 2005

    Report

    Report Number
    9710629-2005-00006
    Event Type
    Other
    Date Received
    June 29, 2005
    Date of Event
    May 3, 2005
    Report Date
    June 27, 2005
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BI-LATERAL SAGITAL SPLIT OSTEOTOMY IN 2005. A WEEK AFTER THE SURGERY IT WAS FOUND THAT 3 SCREWS HAVE BROKEN POST OPERATIVELY. A REVISION SURGERY WAS PERFORMED APPROX 2 WEEKS AFTER THE ORIGINAL IMPLANTATION TO REMOVE THE RESORBABLE SCREWS AND REPLACE THEM WITH TITANIUM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE FIXATION SYSTEM SCREW HWC INION LTD. SCR-1215 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other