BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 1163247 · Received September 2, 2008

    Report

    Report Number
    3002719998-2008-00020
    Event Type
    Other
    Date Received
    September 2, 2008
    Date of Event
    January 24, 2008
    Report Date
    August 28, 2008
    Manufacturer
    RTI BIOLOGICS
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE RE-REVIEWED. THE XENOGRAFT PASSED ALL RELEASE REQUIREMENTS PRIOR TO DISTRIBUTION. NO OTHER COMPLAINTS HAVE BEEN ASSOCIATED WITH THIS BATCH. THE GRAFT UNDERWENT TWO VALIDATED STERILIZATION METHODS; BIOCLEANSE AND POST PACKAGING GAMMA IRRADIATION AT A VALIDATED DOSE (25.0 - 31.0 KGY) TO ACHIEVE A STERILITY ASSURANCE LEVEL (SAL) OF 10/6 PRIOR TO RELEASE. MANY FACTORS MAY LEAD TO NON-UNION. EXAMPLES INCLUDE BACTERIAL/VIRAL INFECTION, INFLAMMATION, FOREIGN BODY RESPONSE, OR RELATIVE MOVEMENT OF THE IMPLANT WITHIN SURROUNDING TISSUE. FAILURE OF AN IMPLANT TO INCORPORATE INTO SURROUNDING TISSUES MAY BE THE RESULT OF DECREASED BLOOD SUPPLY, WEIGHT, INFECTION, POOR GLYCEMIC CONTROL, NONCOMPLIANCE WITH THERAPY, MEDICATIONS (E.G. STEROIDS), ADJUNCT HARDWARE/IMPLANTS, THE PHYSICAL LOCATION OF THE OSTEOTOMY/SURGICAL SITE, OR A PROLONGED INFLAMMATORY RESPONSE. GIVEN THE REVIEW OF MANUFACTURING PROCESS, INTERNAL RECORDS REVIEW, AND THE CLINICAL COURSE OF THE PATIENT TAKEN ALTOGETHER INDICATE THAT RECIPIENT REACTION IS MORE LIKELY ASSOCIATED WITH AN IDIOSYNCRATIC RESPONSE RATHER THAN AN INTRINSIC PROPERTY OF THE GRAFT OR PROCESSING METHODOLOGY.

    Description of Event or Problem · 1

    ON (B) (6) 2007, PATIENT UNDERWENT A FLATFOOT RECONSTRUCTION PROCEDURE OF THE RIGHT FOOT THAT COMPROMISED OF A FLEXURE TENDON TRANSFER, EVAN'S CALCANEAL OSTEOTOMY, GASTRIC EQUINUS, HALLUS VALGUS, AND A SECOND HAMMERTOE REPAIR. THE RESULTS OF THE EVAN'S CALCANEAL OSTEOTOMY PROCEDURE WAS COMPLETE NONUNION. ON (B) (6) 2008, THE GRAFT WAS EXPLANTED. INFECTION WAS NOTED NOT TO BE PRESENT AT THE TIME OF EXPLANTATION. SAMPLES OF BONE AND GRANULOMA SENT FOR PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE XENOGRAFT LYC RTI BIOLOGICS 1-070313

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other TITANIUM (MITEK) BONE ANCHOR