BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 3800248 · Received April 30, 2014

    Report

    Report Number
    3034525-2014-00026
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 29, 2014
    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

    REVIEWED SURGEONS DATABASE REPORT WHICH STATED THAT FOLLOW UP ON A PATIENT AFTER FIVE YEARS FOUND A NON-UNION OF A FRACTURE WITH A BROKEN IM NAIL. THE SURGEON PERFORMED AN EXCHANGE NAIL PROCEDURE TO REPAIR THE FRACTURE AND REPLACE THE NAIL. REVIEW OF THE PATIENT X-RAYS CONFIRMS THE NON-UNION, THE BROKEN NAIL AT THE NON-UNION SITE AND THE NEW IM NAIL WHICH WAS IMPLANTED. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258334 STANDARD IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization