BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 2161969 · Received March 23, 2011

    Report

    Report Number
    3002719998-2011-00001
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    April 23, 2010
    Report Date
    March 21, 2011
    Manufacturer
    RTI BIOLOGICS
    Product Code
    MQV
    PMA / PMN Number
    K072327
    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 NON-UNION. EXAMPLES INCLUDE DECREASED BLOOD SUPPLY, WEIGHT, INFECTION, POOR GLYCEMIC CONTROL, NONCOMPLIANCE WITH THERAPY, MEDICATIONS (E.G. STEROIDS), ADJUNCT HARDWARE/IMPLANTS, THE PHYSICAL LOCATION OF THE SURGICAL SITE, OR A PROLONGED INFLAMMATORY RESPONSE. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 3-080228 PASSED ALL RTI 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.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT UNDERWENT A GASTROCNEMIUS RECESSION AND AN EVANS CALCANEAL OSTEOTOMY OF THE LEFT FOOT. A 12MM EVANS BONE WEDGE XENOGRAFT WAS IMPLANTED. ON AN UNKNOWN DATE IN (B)(6) 2010, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER (MQV) MQV RTI BIOLOGICS 3-080228

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention DARCO PIA 6MM LOCKING PLATE WITH 4 LOCKING SCREWS