BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI ANGULAR STABLE LCKNG SCR T25 48MM F/IM NAILS-STER

    MDR report key: 2893768 · Received January 2, 2013

    Report

    Report Number
    8030965-2013-00006
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K090241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    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 TI CANNULATED FEMORAL NAIL CONSTRUCT ON (B)(6) 2012. SINCE (B)(6) 2012, THE PATIENT HAD BEEN HAVING SLOW PROGRESS AS REVEALED THROUGH X-RAYS TAKEN ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE IN THE LEFT FEMUR DUE TO A NON-UNION. PATIENT WAS REVISED WITH COMPETITORS HARDWARE. NO COMPLICATIONS FROM THE SURGERY WERE REPORTED. THIS IS 5 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661 5.0MM TI ANGULAR STABLE LCKNG SCR T25 48MM F/IM NAILS-STER 5.0MM TI ANGULAR STABLE LCKNG SCR HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention NAIL, HELICAL BLADE, LOCKING SLEEVE, SCREWS