BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE

    MDR report key: 3030767 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00841
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH FEMORAL NAIL AND SCREW CONSTRUCT ON (B)(6) 2012. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY, DUE TO A NON-UNION. DURING REVISION, ONE LOCKING SCREW WAS DISCOVERED BROKEN. SURGEON REMOVED ALL HARDWARE, WHICH INCLUDED THE NAIL AND TWO LOCKING SCREWS. PATIENT WAS REVISED WITH RECON NAIL AND TWO LOCKING SCREWS. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135012 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention