BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3970431 · Received July 31, 2014

    Report

    Report Number
    1030489-2014-03370
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    October 26, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    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 DEVELOPED 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 ON (B)(6) 2009: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: CERVICAL PSEUDOARTHROSIS, INSTABILITY C4-5, C5-6, AND UNDERWENT THE FOLLOWING PROCEDURE: POSTERIOR CERVICAL FUSION WITH FACET SCREW ROD INSTRUMENTATION C4 TO 6 AND POSTEROLATERAL BONE GRAFT USING INFUSE BONE MORPHOGENIC PROTEIN. AS PER THE OP NOTES, THE INFUSE BONE MORPHOGENIC PROTEIN AND GELFOAM WAS PLACED OVER THE DECORTICATED FACET BILATERALLY FOR THE BONE FUSION. THIS WAS DONE AFTER COPIOUS BACITRACIN PULSE LAVAGE IRRIGATION WAS DONE TO WASH THE WOUND OUT. HEMOSTASIS WAS ENSURED AND THE WOUND WAS CLOSED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448126 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110803AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other