BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLO-PURE WEDGE

    MDR report key: 2644301 · Received June 13, 2012

    Report

    Report Number
    3002719998-2012-00021
    Event Type
    Injury
    Date Received
    June 13, 2012
    Report Date
    June 8, 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: ACCORDING TO THE MFG RECORDS, THE GRAFT WAS MFG TO SPEC. 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. NO DEVIATIONS WERE NOTED DURING THE RECORDS RE-REVIEW FOR LOT#: 1-091022. TO DATE, RTI HAS MFG (B)(4) XENOGRAFTS FROM THIS LOT WITH NO RELATED COMPLAINTS. RESULTS OF INVESTIGATION: MANY FACTORS MAY LEAD TO NON-UNION. EXAMPLES INCLUDE DECREASED BLOOD SUPPLY, WEIGHT, INFECTION, POOR GLYCEMIC CONTROL, NONCOMPLIANCE WITH THERAPY, MEDICATIONS (EG STEROIDS), ADJUNCT HARDWARE/IMPLANTS, THE PHYSICIAN LOCATION OF THE SURGICAL SITE, OR A PROLONGED INFLAMMATORY RESPONSE. CONCLUSION: GRAFTS ASSOCIATED WITH LOT#: 1-091022 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

    DESCRIPTION OF THE REPORTED COMPLAINT: ON AN UNK DATE, THE PT UNDERWENT A SURGICAL PROCEDURE. A 12 MM EVANS BONE WEDGE XENOGRAFT WAS IMPLANTED. AT FIRST, PROGRESSED MODERATELY, THEN FAILED 6 - 12 MONTHS POST OPERATIVELY. IT WAS REPORTED THAT THE PT EXPERIENCED PARTIAL NON-UNION, SWELLING, AND PAIN WITHOUT SUSPICION OF INFECTION. REVISION SURGERY WAS PERFORMED AT AN UNK DATE IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLO-PURE WEDGE BOVINE BONE VOID FILLER (MQV) MQV RTI BIOLOGICS 1-091022

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention NOT PROVIDED