BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFN 011 130 DEGREE L240 TAN GREEN

    MDR report key: 2450460 · Received February 9, 2012

    Report

    Report Number
    8030965-2012-00045
    Event Type
    Injury
    Date Received
    February 9, 2012
    Report Date
    January 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDW
    PMA / PMN Number
    K970097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED. PT IMPLANTED ON (B)(6) 2011 WITH PFN (PROXIMAL FEMORAL NAIL) FOR A SUBTROCHANTERIC FEMUR FRACTURE RIGHT, REVERSE FRACTURE DISCOVERED THE NAIL WAS BROKEN ON AN UNK DATE. PT WAS RETURNED TO OPERATING ROOM ON AN UNK DATE FOR MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFN 011 130 DEGREE L240 TAN GREEN PFN JDW SYNTHES GMBH 2100465

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention