BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALLU-C PLATE SIZE 2 RIGHT

    MDR report key: 1361064 · Received January 12, 2009

    Report

    Report Number
    9615741-2009-00003
    Event Type
    Other
    Date Received
    January 12, 2009
    Date of Event
    September 19, 2008
    Report Date
    January 12, 2009
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PLATE WAS BROKEN AT THE MIDDLE HOLE. THE X-RAYS PERFORMED AFTER BREAKAGE OF THE PLATE SHOW THAT THE HALLU-C PLATE WAS IMPLANTED MORE DISTALLY THAN RECOMMENDED IN THE SURGICAL TECHNIQUE. CONSEQUENTLY, A HOLE WAS POSITIONED ON THE JOINT LINE WHICH IS THE AREA WHERE MOST OF THE LOAD IS CONCENTRATED. IT IS CONSIDERED LIKELY THAT THIS COULD HAVE LED TO THE BREAKAGE OF THE PLATE. A REVIEW OF THE MANUFACTURING RECORD FOUND NO ANOMALIES DURING THE MANUFACTURING PERIOD OF THE PRODUCT. A REVIEW OF THE COMPLAINT SYSTEM FOR THE PAST TWO YEARS SHOWS THAT THIS INCIDENT IS THE SECOND REPORT OF A BREAKAGE OF HALLU-C PLATES. (B)(4). PRIOR TO RELEASE, VISUAL AND DOCUMENTATION INSPECTION FOR ALL HALLU-C PLATES IS CONDUCTED. GIVEN THE DESCRIPTION OF THE EVENT, THE ROOT CAUSE IS A NORMAL WEAR OF THE DEVICE. NO CORRECTIVE ACTION HAS BEEN TAKEN AT THIS TIME. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE DISTRIBUTOR SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT FROM (B)(6): A HALLU-C PLATE BROKE. A REVISION SURGERY WAS PERFORMED FOUR YEARS AFTER THE FIRST SURGERY. RADIOGRAPHS TAKEN AFTER THE BREAKAGE SHOW THAT THE HALLU-C PLATE WAS IMPLANTED MORE DISTALLY THAN RECOMMENDED IN THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU-C PLATE SIZE 2 RIGHT FOREFOOT FIXATION PLATE HRS NEWDEAL S.A. B138

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention