BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4348847 · Received December 20, 2014

    Report

    Report Number
    1030489-2014-04805
    Event Type
    Injury
    Date Received
    December 20, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    IT WAS REPORTED THAT ON "(B)(6) 2010, THE PATIENT PRESENTED AT HOSPITAL, WHERE THE SURGEON PERFORMED A SURGICAL PROCEDURE: THE DECOMPRESSIVE LAMINECTOMY WITH RIGHT L4 AND L5 FORAMINOTOMIES, THE POSTEROLATERAL FUSION, L4-5, AND THE POSTERIOR INSTRUMENTATION, L4-5 WITH SPINAL USA TITANIUM HARDWARE. ON (B)(6) 2010 THE PATIENT PRESENTED AT HOSPITAL, WHERE THE SURGEON PERFORMED A SURGICAL PROCEDURE: THE ANTERIOR RETROPERITONEAL EXPOSURE AND THE ANTERIOR INTERBODY FUSION OF L4-5 USING INFUSE. AS A RESULT OF THE USE OF INFUSE AND THE LT-CAGE IN THIS LUMBAR FUSION SURGERY, PATIENT NOW SUFFERS FROM ECTOPIC BONE GROWTH AND CHRONIC PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839355 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R