BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW

    MDR report key: 2802838 · Received October 24, 2012

    Report

    Report Number
    2520274-2012-02527
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A TFN LAG SCREW REMOVAL PROCEDURE. THE PATIENT WAS IMPLANTED WITH A TFN CONSTRUCT ON AN UNKNOWN DATE. THE PATIENT WAS RETURNED TO SURGERY FOR REMOVAL OF THE LAG SCREW DUE TO ARTHRITIS AT WHICH TIME THE PATIENT WAS REVISED TO A TOTAL HIP. WHILE THE LAG SCREW WAS BEING REMOVED, THE FLANGES ON THE INSERTER EXTRACTOR BECAME BENT, RENDERING THE DEVICE UNUSABLE. THE SURGEON USED ANOTHER INSERTER TO REMOVE THE LAG SCREW. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW LAG SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention