BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2865388 · Received October 16, 2012

    Report

    Report Number
    9617083-2012-00029
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: RESISTANCE TO INSERTION WAS VERY HIGH AND THE APPLIED TORQUE EXCEEDED THE TORSIONAL STRENGTH OF THE SCREW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SCL RECONSTRUCTION SURGERY, BONE PATELLAR TENDON BONE GRAFT, THE SCREW FRACTURED IN THE MIDDLE AND THE THREADED END REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0412PH303

    Patients

    Seq Age Sex Outcome Treatment
    1