BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIS BONE SCREW SIZE UNKNOWN

    MDR report key: 3893628 · Received June 9, 2014

    Report

    Report Number
    3004983210-2014-00012
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    October 18, 2011
    Report Date
    May 21, 2014
    Manufacturer
    TORNIER INC.
    Product Code
    HWC
    PMA / PMN Number
    K090139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT REPORTED BY A TRAINED HEALTHCARE PROFESSIONAL. WITHOUT INFORMATION REGARDING THE SURGICAL PROCEDURE AND X-RAYS IT IS EXTREMELY DIFFICULT TO DETERMINE WHAT PARTS MAY HAVE BEEN INVOLVED IN THIS ISSUE. ALSO, WITHOUT ANY RELEVANT PATIENT INFORMATION (PATIENT COMPLIANCE, ACTIVITY LEVEL, HEALTH STATUS, ALLERGIES, ETC.) IT IS IMPOSSIBLE TO DETERMINE IF THERE MAY HAVE BEEN OTHER CONTRIBUTING ISSUES. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THE INFORMATION PROVIDED IS VERY LIMITED. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS REMOVED, MY ANKLE WAS FUSED USING A TORNIER BRACE DEVICE. THREE OF THE SCREWS BEGAN TO BACK OUT CAUSING PAIN AND THE DEVICE NEEDING TO BE REMOVED. UNKNOWN WHICH THREE SCREWS WERE BACKING OUT. STABILIS DEVICE AND SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334416 STABILIS BONE SCREW SIZE UNKNOWN NONE HWC TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention