BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 3061831 · Received March 29, 2013

    Report

    Report Number
    3002719998-2013-00029
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    March 28, 2013
    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: BATCH IDENTIFIER(S), UNIQUE SERIAL IDENTIFIER(S), OR SURGEON IDENTIFICATION ASSOCIATED WITH THIS REPORT WAS NOT PROVIDED. RTI WAS UNABLE TO CONDUCT A THOROUGH INVESTIGATION OF ASSOCIATED MANUFACTURING AND INTERNAL RECORDS. THE RESULTS OF OUR INTERNAL INVESTIGATION WAS LIMITED TO A COMPREHENSIVE REVIEW OF THE MANUFACTURING PROCESS FOR CANCELLO-PURE WEDGE GRAFTS AS NO BATCH NUMBER, UNIQUE SERIAL NUMBER, OR PATIENT INFORMATION WAS PROVIDED. CANCELLO-PURE XENOGRAFTS UNDERGO 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. CONCLUSION: A RE-REVIEW OF BIOCOMPATIBILITY VALIDATIONS AND COMPARISON OF 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 BY RTI IN 2009. THE RESULTS OF THIS INVESTIGATION DID NOT IDENTIFY AN AGENT OR EVENT INTRINSIC TO THE GRAFT MATERIAL OR PROCESSING METHODOLOGY THAT WOULD CONTRIBUTE TO THE TYPE OF EXPERIENCE REPORTED IN THIS COMPLAINT. BASED ON LITERATURE REVIEW, IT IS NOT UNCOMMON FOR COMPLICATIONS TO OCCUR IN FOOT AND ANKLE SURGICAL PROCEDURES. NUMEROUS REPORTS DOCUMENT COMPLICATIONS ASSOCIATED WITH THESE PROCEDURES. COMPLICATIONS INCLUDE GENERAL INFLAMMATORY RESPONSES, INFECTIONS, NON-UNION, HARDWARE FAILURE, OR REVISIONS REQUIRING ADDITIONAL PROCEDURES.

    Description of Event or Problem · 1

    DESCRIPTION OF THE REPORTED COMPLAINT: ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE A CANCELLO-PURE WEDGE XENOGRAFT WAS IMPLANTED. ON AN UNKNOWN DATE, APPROXIMATELY 3 WEEKS POST-OP, THE PATIENT DEVELOPED AN INFECTION. UPON EXPLANT, NON-INCORPORATION OF THE GRAFT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129574 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER (MQV) MQV RTI BIOLOGICS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NOT PROVIDED