BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIOABSORBABLE FIXATION SYSTEM

    MDR report key: 888699 · Received October 21, 2004

    Report

    Report Number
    9710629-2004-00005
    Event Type
    Malfunction
    Date Received
    October 21, 2004
    Date of Event
    March 10, 2004
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVENT DESCRIPTION HAS BEEN REQUESTED WITH THE ATTENDING PHYSICIAN WITHOUT ANY SUCCESS. ANY FURTHER INFORMATION WILL BE PROVIDED IN THE SEPARATE REPORT.

    Description of Event or Problem · 1

    BSSO OPERATION, SCREW FAILURE, MANDIBLE KEPT ON SAGGING AFTER SECOND PLACEMENT OF THE SCREWS. POSSIBLE RE-OPERATION WITH THE METAL SCREWS. NO FURTHER INFORMATION AVAILABLE OF PATIENT CONDITION AND POSTOPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIOABSORBABLE FIXATION SYSTEM BONE FIXATION SCREW HWC INION LTD. SCR-1207 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention