BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3815008 · Received April 24, 2014

    Report

    Report Number
    9617083-2014-00011
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: BASED ON THE INFO AVAILABLE, BREAKAGE AT 4 MONTHS AFTER IMPLANTATION FOLLOWING ACL RECONSTRUCTION SURGERY IS UNUSUAL AND HEALING SHOULD HAVE TAKEN PLACE BY THIS TIME. FURTHER INFO HAS BEEN REQUESTED AND THIS REPORT WILL BE UPDATED IF NEW INFO COMES TO LIGHT. DETAILS OF THIRD PARTY MICROSCOPIC ANALYSIS RESULTS HAVE NOT BEEN RECEIVED AT BIOCOMPOSITES. THE DEVICE CANNOT BE CONFIRMED AS BEING A CONTRIBUTING CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 9 X 35MM BIOSTEON INTERFERENCE SCREW WAS BROKEN, VERY CLOSE TO THE TIP OF THE SCREW, AT 4 MONTHS AFTER IMPLANTATION FOLLOWING ACL RECONSTRUCTION SURGERY. THE RESPECTIVE SCREW WAS EXPLANTED AND SENT BY THE DOCTOR TO A THIRD PARTY FOR MICROSCOPIC ANALYSIS. REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248122 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0413PH183

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention