BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.4X12MM STERNALOCK SELF DRILLING SCREW

    MDR report key: 1200243 · Received October 2, 2008

    Report

    Report Number
    1032347-2008-00063
    Event Type
    Other
    Date Received
    October 2, 2008
    Date of Event
    August 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K033740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. ANOTHER SIZE SCREW WAS USED IN THE SAME CASE, SEE 1032347-2008-00064.

    Description of Event or Problem · 1

    STERNAL CLOSURE IN 2008 WHERE PLATES, SCREWS AND WIRE WERE USED. THE PATIENT EXPERIENCED A COUGHING SPELL AT HOME, AND HEARD A SOUND LIKE A CRACK OR A SNAP. RETURNED TO THE DOCTOR THE FOLLOWING MONTH, WHERE A REVISION SURGERY WAS PERFORMED AS THE SCREWS AND PLATES HAD PULLED LOOSE ON THE RIGHT SIDE. IT WAS ALSO NOTED THE LOWER WIRE WAS TORN OFF OF THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4X12MM STERNALOCK SELF DRILLING SCREW BONE SCREW HWC BIOMET MICROFIXATION 163870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE SCREWS WERE USED TO HOLD THE PLATES,| WIRE WAS ALSO USED.