BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3920252 · Received July 8, 2014

    Report

    Report Number
    1030489-2014-03139
    Event Type
    Injury
    Date Received
    July 8, 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)(6). (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 EXPERIENCED LOW BACK PAIN AFTER THE ACCIDENT. AT HER DOCTOR'S VISIT, PATIENT WAS TOLD THAT SHE HAD BROKEN SOME VERTEBRAE. ON (B)(6) 2008, PATIENT UNDERWENT A FUSION PROCEDURE AT L4¿5 USING RHBMP-2/ACS OR PUREGEN. FOLLOWING THE SURGERY, PATIENT VISITED THE DOCTOR BECAUSE OF BLOOD CLOTS SHE DEVELOPED IN HER LEGS. FURTHER, PATIENT CONTINUED HAVING BACK PAIN, WHICH ULTIMATELY DEVELOPED INTO SEVERE, FREQUENT SPASMS. CURRENTLY, PATIENT STILL EXPERIENCES SEVERE SPASMS, LOST FLEXIBILITY, EXPERIENCES EXTREME PAIN IN THE MORNINGS, AND IS VERY STIFF. SHE HAS TROUBLE SLEEPING AT NIGHT BECAUSE OF PAIN. SHE ALSO HAS A HUGE, PAINFUL LUMP NEXT TO HER INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397633 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