BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 2397175 · Received December 27, 2011

    Report

    Report Number
    3034525-2011-00043
    Event Type
    Injury
    Date Received
    December 27, 2011
    Date of Event
    December 12, 2011
    Report Date
    December 27, 2011
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF BROKEN IM NAIL IN DATABASE. SURGEON INDICATES HIGH FEMUR F/X REPAIRED, THEN PT COMPLAINED AND IT WAS FOUND THAT THE NAIL WAS BROKEN. INDICATIONS OF NON-UNION HIGH ON THE FEMUR ON AN OBESE PT W/FWB IS CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I.M. NAIL SIGN I.M. NAIL HSB SIGN FRACTURE CARE INTERNATIONAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR