BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILOK SCREW

    MDR report key: 1321125 · Received February 23, 2009

    Report

    Report Number
    9617083-2009-00002
    Event Type
    Other
    Date Received
    February 23, 2009
    Date of Event
    December 30, 2008
    Report Date
    February 13, 2009
    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

    Additional Manufacturer Narrative · 1

    TRAUMATIC SPORTING INJURY LED TO FAILED ACL GRAFT RECONSTRUCTION AND REMOVAL OF GRAFT AND FIXATION SCREWS. A SEPARATE MDR IS FILED FOR THE BILOK ST SCREW USED IN THE SAME PROCEDURE.

    Description of Event or Problem · 1

    PATIENT HAD ACL RECONSTRUCTIONS IN 2007. PT HAD TRAUMATIC INJURY WHILE PLAYING SOCCER IN 2008. ACL SCREW EXPLANTED LATER THAT MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILOK SCREW ACL SCREW HWC BIOCOMPOSITES LTD. BILOK SCREW 11/04-PT2710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention