BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 2889411 · Received November 30, 2012

    Report

    Report Number
    3002719998-2012-00052
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    August 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    RTI BIOLOGICES
    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 EVALUATION. 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 #: 1-090604. 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. TO DATE, RTI HAS MANUFACTURED 157 XENOGRAFTS FROM THIS LOT WITH NO RELATED COMPLAINTS. CLINICAL RECORDS DOCUMENTED LOOSE HARDWARE WHICH REQUIRED SURGICAL INTERVENTION, PARTIAL UNION, AND AN INFECTION APPROXIMATELY SIX MONTHS POST-OPERATIVELY. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 1-090604 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 09/28/2012. 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)(4) 2012, RTI RECEIVED CLINICAL RECORDS FROM (B)(6) HOSPITAL. OPERATIVE NOTES DATED (B)(6) 2012, INDICATED THAT PATIENT UNDERWENT A LEFT FOOT MODIFIED KIDNER PROCEDURE, LEFT FIRST METATARSAL FIRST CUNEIFORM ARTHRODESIS, AND A LEFT FOOT EVANS PROCEDURE WITH IMPLANTATION OF A RTI BONE WEDGE XENOGRAFT. PROGRESS NOTES DATED (B)(6) 2012 INDICATED, THE PATIENT RETURNED FOR FOLLOW-UP COMPLAINING OF ACHING SHARP PAIN TO THE LEFT LATERAL HEEL REGION WITH SEROUS DRAINAGE. X-RAY REPORT SHOWED RETAINED AND LOOSE HARDWARE AND EVIDENCE OF FUSION OF THE FIRST METARTARSOCUNEIFORM. THE PATIENT WAS DESCRIBED ORAL ANTIBIOTICS. OPERATIVE NOTES DATED (B)(6) 2012 INDICATED, THE PATIENT UNDERWENT REMOVAL OF TWO BONE STAPLES. DURING THE PROCEDURE, THE GRAFT WAS INSPECTED AND PARTIAL UNION WAS NOTED. A DRAINAGE POCKET WAS ALSO OBSERVED TO BE PRESENT OVER THE LATERAL CALCANEUS WHICH WAS EVACUATED AND CULTURED. FINAL DEEP WOUND CULTURE RESULTS WERE POSITIVE FOR GROWTH OF DIPHTHEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER (MQV) MQV RTI BIOLOGICES 1-090604

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 3M BONE STABILIZER FIXATION 16 X 15 MM| OPUS MAGNUM KNOTLESS BONE ANCHOR FIXATION| OSTEOMED 4.0 X 40MM SCREW FIXATION| OSTEOMED 4.0 X 34MM SCREW FIXATION