BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1945109 · Received January 3, 2011

    Report

    Report Number
    1030489-2011-00002
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    July 30, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: EHSAN, ET AL IN "TOTAL ELBOW ALLOGRAFTS WITH COLLATERAL LIGAMENT RECONSTRUCTION FOR POSTTRAUMATIC ELBOW INJURIES", J ORTHOP SCI (2010) 15:795-803. (B)(4). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE OBSERVED IN A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT TOTAL ELBOW OSTEOARTICULAR ALLOGRAFT R ECONSTRUCTION BETWEEN (B)(6) 2004 AND (B)(6) 2008 FOR THE MANAGEMENT OF PREVIOUSLY OPERATED ON POST TRAUMATIC ARTHRITIS WITH SEVERE BONE LOSS. THE PROCEDURES CONSISTED OF A TOTAL ELBOW CADAVERIC ALLOGRAFT RECONSTRUCTION WITH GRACILIS TENDON ALLOGRAFT RECONSTRUCTION OF COLLATERAL LIGAMENTS. RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN- 2 (BMP-2) WAS APPLIED TO THE HOST-GRAFT JUNCTIONS OF THE RECONSTRUCTED ELBOW. ONE PATIENT UNDERWENT THE RECONSTRUCTION 27 YEARS AFTER HIS INITIAL INJURY. THE PATIENT EXPERIENCED MILD POST-OP PAIN AND DEMONSTRATED EXCESSIVE ALLOGRAFT RESORPTION, DESPITE BRIDGING CALLOUS AT THE HOST-GRAFT JUNCTION, RESULTING IN SYMPTOMATIC ELBOW INSTABILITY WHICH REQUIRED ALLOGRAFT REMOVAL AND REVISION (OSTEOARTICULAR ALLOGRAFT RECONSTRUCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention