BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 1544404 · Received November 20, 2009

    Report

    Report Number
    3002719998-2009-00025
    Event Type
    Other
    Date Received
    November 20, 2009
    Date of Event
    February 23, 2009
    Report Date
    November 19, 2009
    Manufacturer
    RTI BIOLOGICS
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ACCORDING TO THE MANUFACTURING RECORDS, THE GRAFT WAS MANUFACTURED TO SPECIFICATION. THE GRAFT UNDERWENT TWO VALIDATED STERILIZATION METHODS; BIOCLEANSE AND POST PACKAGING GAMMA IRRADIATION AT A VALIDATED DOSE TO ACHIEVE A STERILITY ASSURANCE LEVEL (SAL) OF 10-6 PRIOR TO RELEASE. RE-REVIEW OF BIOCOMPATIBILITY VALIDATIONS AND COMPARISON OF CURRENT PROCESSING TECHNIQUES, SAMPLES OF REPRESENTATIVE MANUFACTURING EPISODES, FOOT/ANKLE LITERATURE REVIEW AND ADDITIONAL IN VIVO AND IN VITRO TESTING OF VARIOUS BOVINE PRODUCTS WAS CONDUCTED. RESULTS OF INVESTIGATION: MANY FACTORS MAY LEAD TO FOREIGN BODY RESPONSE. EXAMPLES INCLUDE BACTERIAL OR VIRAL INFECTIONS, NON-UNIONS, INFLAMMATION OR RELATIVE MOVEMENT OF THE IMPLANT WITHIN SURROUNDING TISSUE. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 1-080408 PASSED ALL TRI RELEASE CRITERIA PRIOR TO DISTRIBUTION. TO DATE, THE RESULTS OF OUR INVESTIGATION HAVE NOT IDENTIFIED AN AGENT OR EVENT INTRINSIC TO THE GRAFT MATERIAL OR PROCESSING METHODOLOGY THAT WOULD CONTRIBUTE TO THE TYPE OF EXPERIENCE REPORTED IN THIS COMPLAINT. A WRITTEN REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SUBMITTED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT AN EVANS OSTEOTOMY WHERE A CANCELLO-PURE 12MM EVANS BONE EDGE XENOGRAFT WAS IMPLANTED. IT WAS REPORTED THE PATENT RETURNED FOR FOLLOW-UP TWO WEEKS AFTER IMPLANT WITH CONSTANT DRAINAGE FROM THE SURGICAL SITE. AN INSPECTION SHOWED THAT THE GRAFT WAS FULLY DISINTEGRATED, COLLAPSED, AND BROKEN INTO SMALL PIECES INSPITE OF A LOCKING PLATE. THE IMPLANT WAS REJECTED BY THE PATIENT. AT AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE XENOGRAFT MQV RTI BIOLOGICS 1-080408

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other LOCKING PLATE