BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET PERITROCHANTERIC NAILING SYSTEM

    MDR report key: 1430734 · Received August 6, 2009

    Report

    Report Number
    2242816-2009-00076
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    November 13, 2008
    Report Date
    July 20, 2009
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # LOT # MFG. DATE28234 306720 05/21/200814-05036 006770 11/07/2007DHRS WERE REVIEWED, AND NO ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    FOLLOWING STUMBLE DOWN STAIRS IN 2008, FRACTURED NAIL AND DELAYED UNION OF LEFT HIP. PT OUTCOME: PATIENT CHART REPORTS PATIENT IS COMFORTABLE, NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET PERITROCHANTERIC NAILING SYSTEM LAG SCREW, SOLID, FIXED 100MM HSB EBI, LLC 315380

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR