BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2840460 · Received November 20, 2012

    Report

    Report Number
    1030489-2012-02404
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    December 22, 2017
    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

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

    Additional Manufacturer Narrative · 1

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

    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 THE PATIENT UNDERWENT BACK SURGERY USING RHBMP-2/ACS. REPORTEDLY, AFTER SOME TIME, THE PATIENT "DEVELOPED OVERG ROWN BONE, EXPERIENCED SIGNIFICANT PAIN AND SUFFERED OTHER SERIOUS INJURIES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE FACILITY ON (B)(6) 2005. THE DISCHARGE DIAGNOSES WERE DEGENERATIVE L3-4 DISK DISEASE, DEGENERATIVE L5-S1 DISK DISEASE, STATUS POST ANTEROLATERAL DISCECTOMY, INTERBODY ARTHRODESIS AND DECOMPRESSION, POSTOPERATIVE ILEUS, WHICH HAS BEEN RESOLVED, POSTOPERATIVE FEVER AND LEFT PSOAS MUSCLE ENLARGEMENT WITH FLUID COLLECTION, POSSIBLE ABSCESS VERSUS HEMATOMA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R