BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5702478 · Received June 7, 2016

    Report

    Report Number
    1030489-2016-01690
    Event Type
    Injury
    Date Received
    June 7, 2016
    Report Date
    May 16, 2016
    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2012: THE PATIENT WAS PRESENTED WITH SO HE UNDERWENT FOLLOWING OPERATION : L5-S1 BILATERAL FACETECTOMY; L4 LAMINECTOY; L4-L5 POSTERIOR LUMBAR INTERBODY FUSION; L5-S1 POSTERIOR LUMBAR INTERBODY FUSION; L4-L5 POSTEROLATERAL ARTHRODESIS; L5-S1 POSTEROLATERAL ARTHRODESIS; L4 S1 INTERNAL FIXATION WITH INNOVASIS SPINAL ROD SYSTEM; UTILIZATION OF THE STAXX INTERBODY FUSION BIOMECHANICAL DEVICE BILATERALLY AT L5-S1 AND IN THE MIDLINE AT L4-L5; HARVEST OF LOCAL BONE GRAFT; UTILIZATION OF BMP IN POSTEROLATERAL FUSION MASS. AS PER OP NOTES ¿..THE VERTEBRAL BODIES WERE COMPRESSED OVER THE INTERBODY FUSION DEVICES BEFORE THE FINAL TIGHTENING WAS COMPLETED. LATERAL MASS AND TRANSVERSE PROCESSES WERE DECORTICATED AND THE HARVESTED BONE GRAFT ALONG WITH BMP WERE PLACED IN THESE AREAS ¿.¿ ON AN UNKNOWN DATE POST-OP PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358066 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