BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILOK SCREW

    MDR report key: 1239124 · Received November 14, 2008

    Report

    Report Number
    9617083-2008-00001
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 10, 2008
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K003641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BILOK ALLEGEDLY STRIPPED WHILE BEING INSERTED. AT 3 MONTHS POST-OP, PT IS UNHAPPY WITH THE SCREW WHICH IS NOT FULLY IMPLANTED AND PROTRUDES. CLINICAL DECISION TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILOK SCREW ACL SCREW HWC BIOCOMPOSITES LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention