BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE PROXIMAL FEMUR NAIL

    MDR report key: 7369016 · Received March 26, 2018

    Report

    Report Number
    9615128-2018-00003
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 26, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K153536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT AVAILABLE TO THE MANUFACTURER, THUS ITS INSPECTION WAS NOT POSSIBLE. EXAMINATION OF THE PRODUCTION RECORDS OF THE DEVICE INDICATED IT WAS MANUFACTURED ACCORDING TO ITS SPECIFICATION. IT IS NOTED, THAT BREAKAGE OF LONG PROXIMAL FEMUR NAILS ARE REPORTED IN THE LITERATURE (1). (1) IWAKURA ET AL. BREAKAGE OF A THIRD GENERATION GAMMA NAIL: A CASE REPORT AND REVIEW OF THE LITERATURE. CASE REP ORTHOP. 2013; 2013: 172352.

    Description of Event or Problem · 1

    THREE WEEKS AFTER IMPLANTATION OF A PICCOLO COMPOSITE PROXIMAL FEMUR NAIL, THE NAIL BROKE AND WAS REMOVED AND REPLACED WITH ANOTHER NAIL IN A REVISION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214238 PICCOLO COMPOSITE PROXIMAL FEMUR NAIL PF NAIL HSB CARBOFIX ORTHOPEDICS LTD. PPF00729

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention