BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 2920187 · Received January 9, 2013

    Report

    Report Number
    3034525-2012-00051
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 7, 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 BROKEN IM NAIL WHICH IS BROKEN AT THE SITE OF A NON-UNION. POST-OP VIEWS SHOW THAT AN EXCHANGE NAIL PROCEDURE HAD BEEN PREFORMED TO REPLACE THE BROKEN NAIL AND REPAIR THE NON-UNION. NO ADDITIONAL SURGEON COMMENTS ARE AVAILABLE AT THIS TIME, ALTHOUGH THEY HAVE BEEN REQUESTED. CAUSE: NON-UNION OF AN UNDETERMINED AMOUNT OF TIME WITH SOME LEVEL OF (B)(4) BY PATIENT. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11253 STANDARD IM NAIL STANDARD IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR