BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN FIN NAIL

    MDR report key: 2200771 · Received July 28, 2011

    Report

    Report Number
    3034525-2011-00030
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K043200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTS OF A BROKEN FIN NAIL AT F/U. REVIEW OF PT X-RAYS SHOWS FIN NAIL BROKEN AT THE PROXIMAL SLOT. SURGEON REPLACED BROKEN FIN NAIL WITH A STANDARD I. M. NAIL. CAUSE OF THE BREAKAGE WAS FULL WEIGHTBEARING ON NONUNION WITH A VERY HIGH FEMUR FRACTURE. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN FIN NAIL SIGN FIN NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) F10X280 003495 OR 004393

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization