BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA 10 SM 130 L200 TAN

    MDR report key: 2243849 · Received September 7, 2011

    Report

    Report Number
    8030965-2011-00597
    Event Type
    Injury
    Date Received
    September 7, 2011
    Report Date
    August 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) INDICATES THE FOLLOWING: (B)(6) PATIENT WITH LEFT SUBTROCHANTERIC TRANSVERSE FRACTURE AFTER A FALL. TREATED WITH PFNA NAIL AND BLADE. POSTOPERATIVELY, PATIENT WAS BEDRIDDEN DUE TO PULMONARY COMPLICATIONS. TWO WEEKS POSTOPERATIVELY, PATIENT STARTED PHYSIOTHERAPY WITH NO WEIGHT BEARING AND EXPERIENCED REOCCURRENCE OF PAIN IN LEFT HIP. X-RAY SHOWED BACKOUT OF THE BLADE. AT PATIENT CHECK UP, INFECTION WAS NOTED. THIS IS THE FIRST OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA 10 SM 130 L200 TAN NONE KTT SYNTHES GMBH 2742002

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention BLADE