BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE

    MDR report key: 2904881 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00086
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A SURGERY ON (B)(6) 2011, A PATIENT WAS IMPLANTED WITH A TIBIA NAIL. A FOLLOW UP X-RAY REVEALED A NON-UNION. ON (B)(6) 2012, THE PATIENT HAD SURGERY TO REMOVE THE HARDWARE. THE SURGEON REAMED THE CANAL TO INCREASE BLOOD FLOW TO THE BONE AND PROMOTE HEALING. THE PATIENT WAS THEN IMPLANTED WITH A LARGER DIAMETER NAIL, END CAP, AND THREE SCREWS. THIS IS 1 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12112 8MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE NAIL JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SCREWS