BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IM NAIL

    MDR report key: 2870147 · Received December 3, 2012

    Report

    Report Number
    3034525-2012-00039
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 3, 2012
    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 SURGEONS DATABASE REPORT INDICATES A NEED FOR AN EXCHANGE NAIL SURGERY TO REPAIR A NON-UNION WHICH HAD A PREVIOUS SIGN NAIL IMPLANTED. POST-OP PATIENT X-RAYS CONFIRM NON-UNION. SURGEON COMPLETED SURGERY BY REPLACING NAIL WITH A LARGER SIGN NAIL, REFRESHING THE F/X AND APPLYING BONE GRAFT. SURGERY WAS DONE DUE TO NEED TO REPAIR NON-UNION ONLY, NO BREAKAGE OF IMPLANTS REPORTED. NO INDICATION OF PRODUCT DEFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization