BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILOK SCREW

    MDR report key: 423524 · Received October 18, 2002

    Report

    Report Number
    9617083-2002-00015
    Event Type
    Other
    Date Received
    October 18, 2002
    Date of Event
    August 15, 2002
    Report Date
    October 16, 2002
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A KNEE INFECTION WAS REPORTED A FEW WEEKS AFTER ACL SURGERY. MANY OTHER INSTRUMENTS AND PRODUCTS WERE USED DURING THE SURGERY. THE CAUSE OF THE INFECTION WAS UNASCERTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILOK SCREW ACL INTERFERENCE SCREW HWC BIOCOMPOSITES LTD. 7 X 25MM TAPERED & 7 X 30MM 02/02-PT112G & 07/01-PT266

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention