BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 2211291 · Received August 3, 2011

    Report

    Report Number
    8030965-2011-00522
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    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 LETTER WAS RECEIVED FROM AN ATTORNEY REGARDING A PATIENT THAT WAS IMPLANTED WITH A PFNA NAIL AND THE NAIL BROKE SOMETIME IN 2006. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL NONE HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention