BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 3143038 · Received May 23, 2013

    Report

    Report Number
    3034525-2013-00023
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    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

    REVIEW OF SURGICAL DATABASE SHOWS A SURGEON COMMENT ABOUT THE PT ON FWB, NO FOLLOW UP, SUBSEQUENT FALL FROM STAIRS WITH INJURY TO OPERATED LIMB. THE FALL CAUSED A F/X AT THE PROXIMAL FEMUR WHICH IS AT THE DISTAL END OF THE IM NAIL. THE SURGEON INDICATES EXCHANGE NAIL SURGERY. NO BREAKAGE OF THE NAIL WAS NOTED. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230048 SIGN IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization