BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONSTRUCTION NAIL R1.5, TI, LEFT 10X300 MM X 12

    MDR report key: 2221587 · Received August 18, 2011

    Report

    Report Number
    9610622-2011-00376
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K102992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THREE AND 6 MONTH F/U'S SHOWED NO TRAUMA. ON (B)(6) 2011, PT FELT INCREASING PAIN AND AN X-RAY ON (B)(6) 2011 SHOWED NAIL FRACTURED. REVISION SURGERY TO REMOVE NAIL AND APPLY A DHS PLATE. REMOVAL OF THE DISTAL PORTION OF THE NAIL ITSELF WAS EXTREMELY DIFFICULT. AN OSTEOTOMY WAS PERFORMED ON THE LATERAL CORTEX OF THE FEMUR TO TRY AND GET PURCHASE ON THE NAIL. IN THE END, BURR HOLES HAD TO BE DRILLED INTO THE PROXIMAL PORTION OF THE DISTAL FRAGMENT OF NAIL TO LEVERAGE IT OUT. BONE GRAFT, INJECTABLE BONE SUB AND OP-1 HAD TO BE USED AS WELL AS A DHS TO CORRECT FRACTURE. REMOVAL OF NAIL ITSELF TOOK OVER 4 HOURS, TOTAL REVISION SURGERY TIME ALMOST 8 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTRUCTION NAIL R1.5, TI, LEFT 10X300 MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K869689

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R