BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II 09 125 DEGREE L240 TAN

    MDR report key: 2211275 · Received August 3, 2011

    Report

    Report Number
    8030965-2011-00523
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6), INDICATES A PT WAS IMPLANTED WITH A PFNA-II NAIL. AFTER ONE YEAR, PT FELT PAIN AND NON-UNION AND NAIL BREAKAGE WAS NOTED ON X-RAY TAKEN ON UNK DATE. PT WAS REVISED TO A LONG NAIL. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA-II 09 125 DEGREE L240 TAN : PFNA-II 09 125 DEGREE L240 TAN JDW SYNTHES GMBH 2376288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention