BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 2920160 · Received January 9, 2013

    Report

    Report Number
    3034525-2013-00004
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 8, 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

    SURGEONS DATABASE REPORT STATES THAT A NON-UNION WAS FOUND ON FOLLOW-UP WITH AN ATTEMPT TO REPAIR BY BONE GRAFT. THAT PROCEDURE FAILED TO FIX THE ISSUE OF THE NON-UNION SO THE SURGEON DECIDED TO DO AN EXCHANGE NAIL PROCEDURE. THE EXCHANGE NAIL WAS DONE WITH A GOOD RESULT. CAUSE: A NON-UNION WHICH COULD NOT BE REPAIRED BY BONE GRAFT ALONE. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11113 STANDARD IM NAIL STANDARD IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization