BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I. M. NAIL

    MDR report key: 1952084 · Received January 4, 2011

    Report

    Report Number
    3034525-2011-00001
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS PT WITH AN I. M. NAIL IMPLANTED IN THE FEMUR FELL ON HIS HIP AND BROKE THE TIP OF THE NAIL. THE PT MAY HAVE BEEN INTOXICATED AT THE TIME. SURGERY WAS REQUIRED TO REPLACE THE NAIL. PT X-RAY SHOWS A DISTAL NAIL BREAK ON A RETROGRADE FEMUR PLACEMENT. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I. M. NAIL STANDARD I. M. NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) 100320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization