BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Ø9MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/RT

    MDR report key: 3052085 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-01004
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K070843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANTED DATE INDICATED AS SOMETIME IN (B)(6) 2012. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORDS REPORT STATES THAT A REVIEW FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FEMORAL NECK FRACTURE AND WAS IMPLANTED WITH A NAIL CONSTRUCTING OF FOUR SCREWS AND END CAP IN (B)(6) 2012. ON (B)(6) /2013, THE SURGEON PERFORMED A REMOVAL PROCEDURE OF THE IMPLANTED NAIL, FOUR SCREWS AND END CAP DUE TO A NON-UNION WITH TWO BROKEN SCREWS AT THE MEDIAL SIDE OF THE NAIL TOWARDS THE CENTER BODY. THESE PARTS WERE REPLACED WITH THREE 6.5MM CANNULATED SCREWS. X-RAYS WAS TAKEN FOR THE PATIENT A FEW WEEKS PRIOR TO REMOVAL AND THE TWO SCREWS WERE INTACT. THIS REPORT IS FOR A Ø9MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL. THIS IS 1 OF 6 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154643 Ø9MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/RT HSB SYNTHES MONUMENT 6179347

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention