BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSITE TITANIUM 5MM

    MDR report key: 2517706 · Received December 29, 2011

    Report

    Report Number
    3004983210-2011-00013
    Event Type
    Other
    Date Received
    December 29, 2011
    Date of Event
    December 9, 2011
    Report Date
    December 21, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    MAI
    PMA / PMN Number
    K083268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    PT HAD ANCHORS IMPLANTED SIX MONTHS AGO FOR CHRONIC PAIN AND SWELLING OF THE HEEL. X-RAYS AT THAT TIME REVEALED "SPURRING OF THE LEVEL OF THE ACHILLES ATTACHMENT POSTERIOR HEEL AND SOME SQUARING OF THE SUPERIOR TUBEROSITY OF THE CALCANEUS." PT HAS HAD A DRAINING SINUS TRACT SINCE THAT TIME, DESPITE ORAL ANTIBIOTICS, AND SEVERAL INCISIONS AND DRAINAGE PROCEDURES TO REMOVE POLYESTER SUTURE MATERIAL. PT REQUIRED RETURN TO OPERATING ROOM FOR REMOVAL OF ANCHORS AND PLACEMENT OF OSTEOSET BEADS WITH VANCOMYCIN. SURGEON BELIEVES INTERNAL IMPLANTED HARDWARE IS CAUSING THE CONTINUED DRAINAGE AND INFECTION. FINDINGS INTRAOPERATIVELY INCLUDED EROSION AROUND IMPLANT WITH LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSITE TITANIUM 5MM NONE MAI TORNIER INC. BB0110312

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR