BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL

    MDR report key: 1871286 · Received October 13, 2010

    Report

    Report Number
    1719045-2010-00296
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT EXPERIENCED OPEN INJURY SECONDARY TO RAILROAD TIES FALLING ON LEG. PT WAS IMPLANTED WITH TIBIAL NAIL AND RETROGRADE FEMORAL NAIL. PT'S GREAT TOE WAS PARTIALLY AMPUTATED. PT STARTED TO HEAL. PT COMPLAINED OF PAIN AND BONE SCAN SHOWED SIGNS OF INFECTION. INFECTED TIBIAL NAIL WAS REMOVED (B)(6)2010. CANAL WAS CLEANED, BIOPSY AND CULTURES TAKEN. SURGEON IMPLANTED ANTIBIOTIC NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL TIBIAL NAIL HSB SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention