BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192719 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02571
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 UNDERWENT AN ANTERIOR L5-S1 FUSION USING RHBMP-2/ACS. THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005, THE PATIENT PRESENTED FOR PATHOLOGICAL EVALUATION. ON (B)(6) 2005, THE PATIENT PRESENTED WITH L5-S1 DISK DEGENERATIVE DISEASE. THE PATIENT UNDERWENT COMPLETE ANTERIOR L5-S1 DISKECTOMY, ANTERIOR INTERBODY L5-S1 FUSION AND PLACEMENT OF TRANS AXIAL INTERBODY IMPLANT. AS PER OP NOTES ".....THE DISK SPACE WAS PACKED WITH A MEDIUM-SIZE BOX OF RHBMP-2 AFTER IT WAS APPROPRIATELY PREPARED. THIS WAS TO SERVE AS THE FUSION MATERIAL . THE SIZING WAS DONE TO A 45MM SIZE. 45MM 9X12 IMPLANT WAS SELECTED AND SCREWED INTO POSITION. ." NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6)-2005, THE PATIENT UNDERWENT AN AXIAL LUMBAR INTERBODY FUSION AT L5-S1 WHERE RHBMP-2/ACS WAS IMPLANTED. IN 2006, THE PATIENT WAS DIAGNOSED WITH OSTEOLYSIS, PSUEDOARTHROSIS THAT HAS REQUIRED MEDICAL TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292785 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 00044 YR Required Intervention