BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE DISTAL FEMUR PLATE

    MDR report key: 7230093 · Received January 31, 2018

    Report

    Report Number
    9615128-2018-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    October 16, 2017
    Report Date
    January 31, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K143496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PLATE WAS RECEIVED AND UNDERWENT EXAMINATION BY THE MANUFACTURER. DIMENSIONAL EXAMINATION OF THE PLATE AND MICROSCOPIC INSPECTION INDICATED THAT THE PLATE WAS MANUFACTURED ACCORDING TO ITS SPECIFICATION. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED PLATE DID NOT REVEAL A DEVIATION FROM SPECIFICATION. IT IS ASSUMED THAT THE PLATE BROKE DUE TO PATIENT NON-COMPLIANCE WEIGHT-BEARING INSTRUCTIONS TOGETHER WITH IMPLANT FATIGUE. IT SHOULD BE MENTION, THAT THE BROKEN PLATE WAS REMOVED AND REPLACED BY A LONGER CARBOFIX DISTAL FEMUR PLATE WITH NO ADDITIONAL CONSEQUENCES.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT HAD SURGERY TO REPAIR A DISTAL THIRD FRACTURE OF THE LEFT FEMUR ABOVE A TOTAL KNEE PROSTHESIS. A PICCOLO COMPOSITE DISTAL FEMUR PLATE WITH 14 HOLES WAS USED. ABOUT 8 WEEKS POST-OPERATION, THE PLATE BROKE AND WAS REMOVED AND REPLACED BY A LONGER CARBOFIX PLATE WITH NO ADDITIONAL CONSEQUENCES. BASED ON INFORMATION PROVIDED TO THE COMPANY, THE PATIENT WAS CONSIDERED TO BE NON COMPLIANT AFTER HIS SURGERY AND HE WAS WEIGHT-BEARING AGAINST THE PHYSICIAN'S ADVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73465 PICCOLO COMPOSITE DISTAL FEMUR PLATE INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. 91307

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention