BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 2889412 · Received November 30, 2012

    Report

    Report Number
    3002719998-2012-00053
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    February 28, 2012
    Report Date
    November 30, 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 REMAINS IMPLANTED. RTI CONDUCTED A RE-REVIEW OF THE PRODUCT HISTORY RECORD, STERILIZATION RUN REPORTS, QUALITY ASSURANCE/ QUALITY CONTROL REVIEWS, LIMUS AMEBOCYTE LYSATE (LAL) TEST RESULTS AND RELEASE RECORDS ASSOCIATED WITH THIS LOT. RESULTS OF INVESTIGATION: ACCORDING TO THE MANUFACTURING RECORDS THE GRAFT WAS MANUFACTURED TO SPECIFICATION. NO DEVIATIONS WERE NOTED DURING THE RECORDS RE-REVIEW FOR LOT#: 1-090625. 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 10-16 PRIOR TO RELEASE. TO DATE, RTI HAS MANUFACTURED (B)(4) XENOGRAFTS FROM THIS LOT. THERE ARE TWO RELATED COMPLAINTS ASSOCIATED WITH THIS LOT, PHYSICIAN, AND FACILITY. CLINICAL RECORDS DOCUMENTED LOOSE HARDWARE WHICH REQUIRED SURGICAL INTERVENTION, EVIDENCE OF BONE FUSION TO THE FIRST METATARSAL CUNEIFORM WITH RETAINED HARDWARE, AND BONE GRAFT INCORPORATION IN GOOD ALIGNMENT. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 1-090625 PASSED ALL RTI RELEASE CRITERIA PRIOR TO DISTRIBUTION. BASED ON THE REVIEW OF THE CLINICAL RECORDS, THE PATIENT'S SURGICAL OUTCOME IS MORE LIKELY THE RESULT OF A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT.

    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 (B)(6) HOSPITAL STAFF REPORTED THE IMPLANT FAILED CREATING A NON-UNION AS WELL AS BEING REJECTED. ON (B)(6) 2012, RTI RECEIVED CLINICAL RECORDS FROM (B)(6) HOSPITAL. OPERATIVE NOTES DATED (B)(6) 2011, INDICATED THAT PATIENT UNDERWENT LEFT FIRST METATARSAL FIRST CUNEIFORM ARTHRODESIS, A LEFT FOOT EVANS PROCEDURE WITH IMPLANTATION OF A RTI BONE WEDGE XENOGRAFT, AND A LEFT GASTROCNEMIUS. PROGRESS NOTES DATED HISTORY AND PHYSICAL NOTES DATED (B)(6) 2011, INDICATED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAINS AND WAS RELEASED THE SAME DAY. PROGRESS NOTES FROM (B)(6) 2012 INDICATED THE PATIENT RETURNED FOR FOLLOW-UP WITH A BURNING PAIN IN THE LATERAL MIDFOOT SECTION OF THE LEFT FOOT. X-RAYS SHOWED THREE BONE STAPLES OVER THE DISTAL LATERAL CALCANEUS WERE LOOSE AND ONE BONE STAPLE WAS BACKED OUT TO THE LATERAL WALL OF THE CALCANEUS IN THE SOFT TISSUE. THERE WAS EVIDENCE OF BONE FUSION TO THE FIRST METATARSAL CUNEIFORM WITH RETAINED SCREWS AND BONE GRAFT INCORPORATION IN GOOD ALIGNMENT. OPERATIVE NOTES DATED (B)(6) 2012 INDICATED THE PATIENT UNDERWENT REMOVAL OF THE LEFT FOOT BONE STAPLE AND LEFT CALCANEUS REMOVAL OF THE LEFT FOOT BONE STAPLE AND LEFT CALCANEUS NON-UNION REPAIR WITH PROGENIX BONE PUTTY. FINAL LEFT CALCANEUS DEEP WOUND CULTURE RESULTS WERE NEGATIVE FOR GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BOLD VOID FILLER (MQV) MQV RTI BIOLOGICS 1-090625

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention OSTEOMED 4.0 X 40MM SCREW FIXATION| 3M BONE STABILIZER| OSTEOMED 4.0 X 34MM SCREW FIXATION| OSTEOMED SCREWS (X3)