BEUDAMED
    FDA Adverse Event Summary report: N

    SPIRAL TACKER

    MDR report key: 33839 · Received July 1, 1996

    Report

    Report Number
    MW1009414
    Date Received
    July 1, 1996
    Date of Event
    January 8, 1996
    Report Date
    June 26, 1996
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THREE DAYS AFTER HERNIA REPAIR SURGERY USING WIRE MESH AND TITANIUM SCREWS, A SMALL LUMP APPEARED ON RPTR'S ABDOMEN. IT WAS PAINFUL AND GRADUALLY BECAME LARGER. BY THE END OF MARCH A SECOND LUMP APPEARED BESIDE THE FIRST ONE. OPERATING SURGEON WAS NOT CONCERNED ABOUT THE LUMP. A CONSULTING SURGEON DID ABDOMINAL X-RAYS AND DISCOVERED 13 SCREWS. 4 WERE EXPLANTED AS THEY HAD BECOME IMBEDDED IN RPTR'S ABDOMINAL WALL. THE SURGEON KEPT 2 SCREWS AND THE PT HAS 2. RPTR DISCUSSED PROBLEM WITH THE CO SALES REP WHO TOLD HER THAT THE SCREWS WERE ONLY INTENDED TO HOLD THE MESH IN PLACE FOR THREE DAYS WHILE IT INTEGRATED. THE REP STRONGLY ENCOURAGED THE PT TO HAVE THE SCREWS EXPLANTED AS THE CO WAS CONCERNED ABOUT INFECTION, 9 OF 13 SCREWS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRAL TACKER Implant TITANIUM SCREW GDW ORIGIN MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR