BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY TIBIAL NAIL

    MDR report key: 1023281 · Received April 1, 2008

    Report

    Report Number
    9680825-2008-00001
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    November 27, 2007
    Report Date
    March 31, 2008
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDS
    PMA / PMN Number
    K961027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBJECTED TO CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE TEST RESULTS CONFIRMED THAT THE MATERIAL CONFORMS TO ORTHOFIX SPECIFICATIONS. NO METALLURGICAL DEFECTS HAVE BEEN DETECTED. THE BREAKAGE OCCURRED DUE TO FATIGUE FAILURE WHICH LIKELY OCCURRED BECAUSE OF EXCESSIVE CYCLIC LOAD APPLICATIONS IN THE ABSENCE OF COMPLETE BONE HEALING. WITHOUT FURTHER INFORMATION ON THE SPECIFIC CLINICAL APPLICATION, IT IS NOT POSSIBLE TO DRAW ANY DEFINITIVE CONCLUSIONS ON THE ROOT CAUSE. ORTHOFIX CONTINUES MONITORING THE PRODUCT ON THE MARKET AND WILL ADVISE IMMEDIATELY IN THE EVENT THAT ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    EIGHT MONTHS AFTER THE IMPLANTATION, THE DEVICE BROKE. NO FURTHER CLINICAL AND MEDICAL INFORMATION WERE AVAILABLE ABOUT THE PATIENT CONDITIONS AND THE CLINICAL APPLICATION. THE PRODUCT WAS RETURNED AND IMMEDIATELY SENT TO A LABORATORY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY TIBIAL NAIL TIBIAL NAIL JDS ORTHOFIX SRL 74933 G013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention