BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 1669051 · Received April 16, 2010

    Report

    Report Number
    3002719998-2010-00003
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 18, 2010
    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 MFG RECORDS THE GRAFT WAS MFR 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 REP MFG EPISODES, FOOT/ANKLE LITERATURE REVIEW AND ADDITIONAL INF 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#: 2-080311 PASSED ALL RTI RELEASE CRITERIA PRIOR TO DISTRIBUTION. DEVICE EVALUATION IN PROCESS. TO DATE, THE RESULTS OF OUR INVESTIGATION HAVE NOT IDENTIFIED AN AGENT OR EVENT INTRINSIC TO GRAFT MATERIAL OR PROCESSING METHODOLOGY THAT WOULD CONTRIBUTE TO THE TYPE OF EXPERIENCE REPORTED IN THIS COMPLAINT. A WRITTEN REQUEST FOR ADDITIONAL INFO HAS BEEN SUBMITTED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PT UNDERWENT A SURGICAL PROCEDURE WHERE A CANCELLO-PURE WEDGE XENOGRAFT WAS IMPLANTED. ON (B) (6) 2010, THE PT 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 2-080311

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention