BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBUTTON DIRECT FIXATION DEVICE, 9MM

    MDR report key: 2970150 · Received February 20, 2013

    Report

    Report Number
    1219602-2013-00047
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH RASH AROUND/ON THE SCAR ON THE OPERATIVE LEG OVER THE LOCATION OF THE ENDOBUTTON. RASH IS INTERMITTENT- IT IS EVIDENT AND THEN FADES WITH NO APPARENT REASON. PATIENT HAS BEEN SEEN BY DERMATOLOGIST SUZANNE GREVELINK WHO CALLED IN TO REQUEST A SAMPLE OF THE TITANIUM. PATIENT IS NOW BEING SEEN BY THE DIRECTOR OF THE DERMATOLOGY DEPARTMENT AT (B)(6), DR (B)(6) WHO WILL PERFORM TESTING ON THE PATIENT AND THE TITANIUM SAMPLE ENVELOPE HAS BEEN SENT TO DR SCHEINMAN CONTAINING AN ENDOBUTTON SAMPLE, THE LIST OF ELEMENTS IN TITANIUM AND THE ENDOBUTTON FAMILY SELL SHEET. REQUEST HAS ALSO BEEN MADE FOR THE OUTCOME OF THE TESTING. DEVICES ALSO IMPLANTED ON THE SAME DATE ARE PARCUS INTERFERENCE SCREW - LOT CODE # 2797 AND LIFE NET SEMI-TENDINITIS ALLOGRAFT # (B)(4). ADDITIONAL INFORMATION CONFIRMED THAT THE PATIENT WAS INITIALLY OPERATED ON 8-10 MONTH AGO AND WILL NOT BE SEEN UNTIL THE END OF THE COLLEGE SEMESTER APPROXIMATELY THREE TO FOUR MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72966 ENDOBUTTON DIRECT FIXATION DEVICE, 9MM ENDOBUTTON DIRECT FIXATION DEVICE, 9MM MBI SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE 50242655

    Patients

    Seq Age Sex Outcome Treatment
    1