BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1945110 · Received January 3, 2011

    Report

    Report Number
    1030489-2011-00003
    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): (RADIOULNAR SYNOSTOSIS). 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.

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE OBSERVED IN A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT TOTAL ELBOW OSTEOARTICULAR ALLOGRAFT RECONSTRUCTION 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 NINE YEARS AFTER HIS INITIAL INJURY. THE PATIENT EXPERIENCED MILD POST-OP PAIN AND DEVELOPED RADIOULNAR SYNOSTOSIS AT THE LEVEL OF THE ULNAR HOST-GRAFT JUNCTION THAT MANIFESTED IN LIMITED ROTATIONAL ARC OF MOTION. THE SYNOSTOSIS WAS RESECTED, AND THE RADIAL HEAD WAS REPLACED 13 MONTHS AFTER ELBOW RECONSTRUCTION, RESTORING HIS ARC OF MOTION. SEVEN MONTHS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED RADIAL HEAD IMPLANT LOOSENING, RESULTING IN CLINICAL ELBOW INSTABILITY, DUE TO NONCOMPLIANCE WITH ACTIVITY RESTRICTIONS.

    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 00030 YR Required Intervention