BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 382413 · Received March 13, 2002

    Report

    Report Number
    MW1024402
    Event Type
    Other
    Date Received
    March 13, 2002
    Date of Event
    March 14, 2001
    Report Date
    March 13, 2002
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH ALLOGRAFT, RIGHT KNEE IN 2001. PT BEGAN HAVING REDNESS BELOW RIGHT KNEE 1 WEEK POST-OP AND WAS STARTED ON KEFLEX ORALLY. INCISION AND DRAINAGE OF LOWER KNEE INCISION WAS PERFORMED ONE MONTH AFTER LARGE AMOUNT OF PURULENT DRAINAGE FOUND. PT STARTED ON CIPRO ORALLY AT THIS TIME. THREE WEEKS LATER, WAS TAKEN TO SURGERY FOR REMOVAL OF TIBIAL SCREW AND SHEATH AND DEBRIDEMENT AND IRRIGATION OF TIBIAL SCREW SITE AND PROXIMAL TIBIAL GRAFT TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TIBIALIS TENDON 330MM X 6MM FTL CRYOLIFE, INC. * *
    2 * INTRAFIX TAPERED SCREW 8-10MM X 30MM HWC MITEK INNOVASIVE 330820 0101024
    3 * CROSS PIN 6.5MM X 50MM HTY MITEK INNOVASIVE 317550 0101005
    4 * INTRAFIX TIBIAL SHEATH 30MM HSH MITEK INNOVASIVE 3830 0101085

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other