BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 2830981 · Received November 14, 2012

    Report

    Report Number
    1719045-2012-01147
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH NAIL AND SCREW CONSTRUCT ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF THE NAIL DUE TO THE NON-UNION OF THE LEFT THE TIBIA. SURGEON RE-REAMED THE CANAL, PLACED A LARGER DIAMETER NAIL AND UTILIZED THE DYNAMIC LOCKING OPTION ON THE NAIL. ALL HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO NEW TIBIA NAIL CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED FALL LEADING UP TO THE NON-UNION OF THE DEVICE. PREVIOUSLY THE PATIENT HAD THE SCREWS REMOVED AT ANOTHER FACILITY. PATIENT'S STATUS POST OPERATIVE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL JDS SYNTHES MONUMENT 6077192

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCREWS