BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2961921 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00482
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    July 2, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 USED 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS EXPERIENCED "MANY COMPLICATIONS SUCH AS PAIN, MAJOR NERVE INJURY AND HAS [PATIENT] CONSTANTLY WORRIED ABOUT THINGS GETTING WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DISC DEGENERATION, L4-L5 AND L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR FUSION L4-L5 AND L5-S1; PARTIAL VERTEBRECTOMY L4 AND L5; ANTERIOR SPACERS X 2; AUTOGRAFT, RHBMP-2 AND ALLOGRAFT. AS PER OP-NOTES, "THE POSTERIOR LONGITUDINAL LIGAMENT WAS IDENTIFIED AND SUBSEQUENTLY THIS WAS ENLARGED. THE FRAGMENT WAS REMOVED WITH KERRISONS AND PITUITARIES AND AN EBI IONIC SPACER 13MM IN HEIGHT WAS INSERTED WITHIN THE VERTEBRAL DEFECT AFTER PERFORMING PARTIAL VERTEBRECTOMIES AT L4 AND L5. THIS ALLOWED EXPOSURE OF THE ENDPLATES WHICH WERE REMOVED WITH LARGE LEKSELL RONGEUR. THIS BONE GRAFT WAS THEN MORSELIZED AND MIXED WITH ALLOGRAFT AND RHBMP-2 AND PLACED AROUND THE CENTRAL POST OF THE SPACER." THE PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH LUMBAR DISC DEGENERATION, L4-L5 AND L5-S1 AND SPONDYLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66119 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110709AAU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention