BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 382399 · Received March 12, 2002

    Report

    Report Number
    MW1024401
    Event Type
    Other
    Date Received
    March 12, 2002
    Date of Event
    December 12, 2000
    Report Date
    March 12, 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, LEFT KNEE IN 2000. PT NOTICED SWELLING AND REDNESS OVER LOWER KNEE IN 2001. FOUR DAYS LATER, THE WOUND BROKE OPEN AND EXODED PUS. CULTURE TAKEN AND PLACED ON KEFLEX: FOUR DAYS LATER PT WAS ADMITTED TO HOSP AND TAKEN TO OR WHERE THE WOUND WAS DEBRIDED, INFECTED TISSUE REMOVED, AND WOUND IRRIGATED. FIVE MONTHS LATER, PT WAS AGAIN TAKEN TO OR AND INFECTED TISSUE, BONE STAPLE AND BONE SCREW AND SHEATH WERE REMOVED FROM LEFT TIBIAL SITE WITH DEBRIDEMENT AND IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TIBIALIS TENDON 345MM X 7MM FTL CRYOLIFE, INC. * *
    2 * CROSS PIN 6.5MM X 50MM HTY MITEK INNOVASIVE 317550 0011033
    3 * INTRAFIX TAPERED SCREW 8-10MM X 30MM HWC MITEK INNOVASIVE 330820 0009052
    4 * INTRAFIX TIBIAL SHEATH 30MM HSH MITEK INNOVASIVE 3830 0010043
    5 * CLEARFIX MENISCAL SCREW 2MM X 10MM HWC MITEK INNOVASIVE 7201 0011009
    6 * RICHARDS BONE STAPLE JDW SMITH & NEPHEW 128694 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other