BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER

    MDR report key: 2913009 · Received January 14, 2013

    Report

    Report Number
    1719045-2013-00105
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WITH TFN NAIL AND HELICAL BLADE CONSTRUCT ON (B)(6) 2011. THE PATIENT RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE REMOVAL WAS DUE TO A MEDIAL MIGRATION, AND CUT OUT OF IMPLANT IN FEMORAL HEAD. SURGEON REMOVED THE HARDWARE AND PERFORMED A TOTAL HIP REPLACEMENT - ARTHROPLASTY. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20741 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER NAIL HSB SYNTHES MONUMENT 6562223

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention HELICAL BLADE