BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 382345 · Received March 14, 2002

    Report

    Report Number
    MW1024399
    Event Type
    Other
    Date Received
    March 14, 2002
    Date of Event
    August 24, 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 TIBIALIS TENDON ALLOGRAFT, RIGHT KNEE IN 2001. PT DEVELOPED PAIN AND SWELLING AT TIBIAL INCISION SITE 3 WEEKS POST-OP. PT WAS TAKEN TO SURGERY 24 DAYS LATER FOR DEBRIDEMENT OF TIBIAL WOUND AND WAS PLACED ON IV ANTIBIOTICS FOR A TOTAL OF SIX WEEKS. (IV GENTAMYCIN AND IV CEFOTAXIME). ORAL CIPRO WAS ALSO GIVEN. PT WAS TAKEN TO SURGERY AGAIN 2 MOS LATER AND THE TIBIAL SCREW AND SHEATH WERE REMOVED AND NECROTIC TENDONOUS MATERIAL REMOVED FROM TIBIAL INCISION AND TIBIAL BONE TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TIBIALIS TENDON 310MM X 7MM FTL CRYOLIFE, INC. * *
    2 * INTRAFIX TIBIAL SHEATH 30 MM HSH MITEK INNOVASIVE 254601 0107047
    3 * CROSS PIN 6.5MM X 50MM HTY MITEK INNOVASIVE 317550 0106089
    4 * INTRAFIX TAPERED SCREW 8-10MM X 30MM HWC MITEK INNOVASIVE 254603 0107046

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other