BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 1813080 · Received August 20, 2010

    Report

    Report Number
    9617083-2010-00006
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSES: USE OF DAMAGED OR BENT DRIVER, FAILURE TO TAP IF BONE PATELLAR TENDON BONE GRAFT USED, GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED, INSERTION OVER A BENT GUIDE WIRE.

    Description of Event or Problem · 1

    SCREW WAS REPORTED TO HAVE BROKEN DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0408PH313

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention