BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 2879156 · Received November 16, 2012

    Report

    Report Number
    3002719998-2012-00048
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    April 11, 2012
    Report Date
    November 16, 2012
    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: THE GRAFT WAS NOT RETURNED TO RTI BIOLOGICS, INC. FOR EVAL. RTI CONDUCTED A RE-REVIEW OF THE PRODUCT HISTORY RECORD, STERILIZATION RUN REPORTS, QA / QUALITY CONTROL REVIEWS, LIMUS AMEBOCYTE LYSATE (LAL) TEST RESULTS AND RELEASE RECORDS ASSOCIATED WITH THIS LOT. RESULTS OF INVESTIGATION: ACCORDING TO THE MFG RECORDS THE GRAFT WAS MANUFACTURED TO SPECIFICATION. NO DEVIATIONS WERE NOTED DURING THE RECORDS RE-REVIEW FOR LOT#: 1-090402. THE GRAFT UNDERWENT TWO VALIDATED STERILIZATION METHODS; BIOCLENSE AND POST PACKAGING GAMMA IRRADIATION AT A VALIDATED DOSE TO ACHIEVE A STERILITY ASSURANCE LEVEL (SAL) OF 10-6 PRIOR TO RELEASE. TO DATE, RTI HAS MANUFACTURED (B)(4) XENOGRAFTS FROM THIS LOT WITH NO RELATED COMPLAINTS. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 1-090402 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

    RTI BIOLOGICS, INC. (RTI) INITIATED AN INVESTIGATION INTO A COMPLAINT REPORTED ON (B)(6) 2012. THE DESCRIPTION OF THE COMPLAINT INDICATED THAT ON (B)(6) 2012, THE PT UNDERWENT A SURGICAL FOOT PROCEDURE WITH IMPLANTATION OF A RTI BONE WEDGE XENOGRAFT. ON (B)(6) 2012 THE PT RETURNED FOR A F/U VISIT COMPLAINING OF SWELLING AND DISCOMFORT. X-RAY SHOWED HARDWARE WAS INTACT, SOME CALLUS FORMATION, PERIOSTEAL REACTION OR HETEROTOPIC OSSIFICATION SUPERFICIAL TO THE LATERAL FIXATION SIDE PLATE. SOME INTERVAL PROGRESSIVE BONY FUSION WAS ALSO OBSERVED. ON (B)(6) 2012, THE PT UNDERWENT HARDWARE REMOVAL AS THE PLATE AND SCREWS WERE LOOSE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GRAFT DID NOT LOOK "HEALTHY" AND WAS REMOVED. FINAL CULTURES WERE NEGATIVE FOR GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER (MQV) MQV RTI BIOLOGICS 1-090402

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SCREWS| PLATE