BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2791986 · Received October 16, 2012

    Report

    Report Number
    2520274-2012-02281
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIA EX NAIL AND LOCKING SCREWS ON AN UNKNOWN DATE. PATIENT RETURNED TO THE SURGEON COMPLAINING THAT THE SCREWS WERE UNCOMFORTABLE AND IRRITATING. SURGEON RETURNED THE PATIENT TO THE OR ON (B)(6) 2012 AND REMOVED TWO (2) 4.0MM DISTAL LOCKING SCREWS. THE TIBIA NAIL WAS INTACT AND REMAINS IMPLANTED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING SCREW, NAIL