BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140487 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02031
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008: THE PATIENT UNDERWENT SPINAL FUSION SURGERY USING RHBMP-2/ACS. ON (B)(6) 2009: THE PATIENT PRESENTED WITH ABNORMAL MATERIAL POSTERIOR TO L5-S1 DISK SPACE, COULD REPRESENT PROGRESSIVE DISC HERNIATION OR EXUBERANT GRANULATION TISSUE, THERE IS ALSO SOME CALCIFIC DENSITY PROJECTING POSTERIOR TO THE DISK SPACE THAT COULD REPRESENT DISPLACEMENT OF BONE GRAFT MATERIAL (B)(6) 2009: THE PATIENT PRESENTED WITH CHRONIC PAIN (B)(6) 2010: THE PATIENT PRESENTED TO THE ER DUE TO LOW BACK PAIN AFTER FALL. ON (B)(6) 2010: THE PATIENT PRESENTED WITH RADICULOPATHY. ON (B)(6) 2011: THE PATIENT PRESENTED WITH INTERVAL INCREASE IN OVERALL CALCIFICATION WITHIN AN APPARENT FUSION MASS ALONG LEFT POSTERIOR ASPECT OF L5-S1 DISK SPACE CAUSING MILD TO MODERATE LEFT LATERAL RECESS STENOSIS AND MAY IMPINGE LEFT S1 NERVE ROOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241071 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other