BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE HUMERAL NAILING SYS

    MDR report key: 3847974 · Received May 15, 2014

    Report

    Report Number
    9615128-2014-00001
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K100497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE INDICATED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT IS A (B)(4)-YEAR-OLD MALE WITH A HISTORY OF METASTATIC RENAL CELL CARCINOMA TO THE LEFT DISTAL HUMERUS. HE UNDERWENT AN INTRAMEDULLARY NAILING OF THE LEFT HUMERUS FOR AN IMPENDING FRACTURE DUE TO HIS METASTATIC RENAL CELL CARCINOMA ON (B)(6) 2013. X-RAYS TAKEN ABOUT 10 MONTHS POST-OPERATION, FOLLOWING PT'S COMPLAINTS, REVEALED A LYTIC LESION AND A DYSPLASTIC HUMERAL DIAPHYSIS WITH EVIDENCE OF FRACTURE OF THE INTRAMEDULLARY ROD DISTALLY. FOLLOWING CURETTAGE AND GRAFTING ADDITIONAL 90/90 PLATING (USING CARBOFIX DIAPHYSEAL PLATES) WITH CABLE WAS PERFORMED, LEAVING THE NAIL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291468 PICCOLO COMPOSITE HUMERAL NAILING SYS INTRAMEDULLARY NAILING SYS HSB CARBOFIX ORTHOPEDICS LTD. QTN01030

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R NEOADJUVANT CHEMOTHERAPY