BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3922583 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03157
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN HER LOWER BACK AND RIGHT LEG. PATIENT WAS DIAGNOSED WITH BONE SPURRING. IN 2006, PATIENT UNDERWENT A LUMBAR SPINAL FUSION AT AN UNKNOWN LEVEL USING RHBMP-2/ACS. FOLLOWING THE SURGERY, PATIENT SUFFERED FROM SEVERE LEG AND BACK PAIN. ON (B)(6) 2011, PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE SCAR TISSUE AND BONE SPURS FROM L4-L5 AND USING RHBMP-2/ACS OR PUREGEN. AFTER THE SECOND SURGERY, PATIENT CONTINUED TO SUFFER FROM SEVERE PAIN IN HER BACK AND LEGS. ON (B)(6) 2011, PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR A DURAL TEAR INFLICTED DURING HER SECOND SURGERY AND ALSO USING RHBMP-2/ACS OR PUREGEN. FOLLOWING THE SURGERY, PATIENT CONTINUES TO SUFFER FROM SEVERE PAIN IN HER BACK AND LEGS, AS WELL AS NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400986 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 Required Intervention