BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION HEXALON ACL/PCL SCREW

    MDR report key: 650821 · Received September 23, 2005

    Report

    Report Number
    9710629-2005-00009
    Event Type
    Malfunction
    Date Received
    September 23, 2005
    Date of Event
    August 24, 2005
    Report Date
    September 22, 2005
    Manufacturer
    INION LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACL RECONSTRUCTION OPERATION: THE SCREW BROKE DURING INSERTION. TIP OF THE BROKEN SCREW REMAINS IN THE FEMORAL BONE TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION HEXALON ACL/PCL SCREW ACL/PCL SCREW HWC INION LTD. ACL-4102 0505011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other