BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3928373 · Received June 18, 2014

    Report

    Report Number
    9617083-2014-00021
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    L0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: DELAY IN SENDING THE 30 DAY MANUFACTURER'S REPORT DUE TO ADMINISTRATION OVERSIGHT. FROM EXAMINATION OF THE RETURNED DEVICE, POSSIBLE SUSPECTED ROOT CAUSE IS THAT THE BONE TUNNEL WAS TOO TIGHT. THIS RESULTS IN EXCESSIVE TORQUE BEING REQUIRED TO INSERT THE SCREW WHICH CAUSES EXCESSIVE FLATTENING OF THE SCREW THREADS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BIOCOMPOSITES ON 22 APRIL 2014. COMPLAINT AND SURGERY DETAILS PROVIDED ARE UNCONFIRMED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356833 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0513PH135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention