BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 1218883 · Received October 30, 2008

    Report

    Report Number
    3002719998-2008-00029
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 24, 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

    INVESTIGATION: NO DEPARTURES WERE NOTED DURING THE RE-REVIEW OF RECORDS FOR BATCH 1-070913. CANCELLO- PURE WEDGE GRAFTS UNDERGO TWO VALIDATED STERILIZATION METHODS; BIOCLEANSE: TO ELIMINATE THE POTENTIAL OF COMMUNICABLE DISEASE TRANSMISSION 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. 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: 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. CONCLUSION: 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 FOOT/ANKLE LITERATURE REVIEW 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) 2008, PT UNDERWENT A OPENING BASE WEDGE OSTEOTOMY OF THE FIRST METATARSAL AND A AKIN OSTEOTOMY OF THE GREAT TOE. THE PT EXPERIENCED A SERIES OF COMPLICATIONS AT THE SURGERY SITE AND WAS SEEN NUMEROUS TIMES FOR TREATMENT. ON (B) (6) 2008, THE PT UNDERWENT IRRIGATION AND DEBRIDEMENT ALONG WITH REMOVAL OF THE XENOGRAFT AND HARDWARE. THE PT RETURNED COMPLAINING OF SEVERE BURNING TYPE OF PAIN AND DISCOMFORT ON (B) (6) 2008, AND WAS REFERRED TO ANOTHER DOCTOR FOR POSSIBLE ALLERGIC REACTION, EVALUATION AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE XENOGRAFT LYC RTI BIOLOGICS 1-070913

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other 4 LOCKING SCREWS| 1 DISTAL SCREW| .045 K-WIRE| 30MM COMPRESSION SCREW| DARCO PLATE