BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE DISTAL FEMUR PLATE

    MDR report key: 10343589 · Received July 30, 2020

    Report

    Report Number
    9615128-2020-00008
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 30, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    UDI-DI
    07290109335292
    PMA / PMN Number
    K143496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INVOLVED AN ONCOLOGICAL PATIENT WITH NONUNION AND LOOSENING OF THE PLATE AFTER TWO YEARS. EXAMINATION OF PRODUCTION RECORDS OF THE INVOLVED IMPLANT INDICATED IT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE IMPLANT WAS NOT AVAILABLE TO THE COMPANY; THUS, ITS PHYSICAL EXAMINATION WAS NOT POSSIBLE. EXAMINATION OF X-RAYS TAKEN AFTER THE INCIDENT, SUGGEST PLATE SHAFT' DISTAL END LOOSENED FROM ONE SCREW. ACCORDING TO THE LITERATURE, COMPLICATIONS FOLLOWING TREATMENT WITH DISTAL FEMUR PLATES, INCLUDING NONUNION AND IMPLANT FAILURE ARE NOT INFREQUENT. STUDIES DEMONSTRATE NONUNION RATES OF UP TO 20% AND LOOSENING RATE OF ABOUT 2% (1). THE RISK OF SUCH INCIDENTS INCREASES IN THE CASE OF PATHOLOGICAL FRACTURES. (1) HOFFMANN MF ET AL., CLINICAL OUTCOMES OF LOCKED PLATING OF DISTAL FEMORAL FRACTURES IN A RETROSPECTIVE COHORT. J ORTHOP SURG RES. 2013; 8: 43.

    Description of Event or Problem · 1

    A DISTAL FEMUR PLATE WAS IMPLANTED (IN ITALY) TO TREAT A PATHOLOGICAL FRACTURE (A PF NAIL AND BONE GRAFT WERE ALSO IMPLANTED IN THE SAME BONE). ABOUT TWO YEARS LATER, X-RAYS REVEALED NONUNION WITH DISCONNECTION OF PLATE SHAFT' DISTAL END FROM ONE SCREW. A REVISION SURGERY WAS PERFORMED IN WHICH THE PLATE WAS REMOVED AND REPLACED WITH A MEDIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810344 PICCOLO COMPOSITE DISTAL FEMUR PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. Distal Femur Plate 91140 07290109335292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention