BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140423 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02027
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    October 25, 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.

    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 ON (B)(6) 2008, THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RH-BMP2/ACS WAS USED. AS PER OP-NOTES, ¿THE CARTILAGINOUS END PLATES OF L3 AND L4 WERE DECORTICATED WITH A SMALL RASP. THE DEPTH AND HEIGHT OF THE DISK SPACE WAS MEASURED BY INSERTING VARIOUS TRIAL INTERBODY SPACERS AND A 10 MM LORDOTIC INTERBODY CAGE WAS CHOSEN AS THE OPTIMAL FIT. THIS WAS PACKED WITH A COMBINATION OF RHBMP-2 AND GRAFT SUBSTITUTE, WHICH WAS THEN INSERTED INTO THE CAGE. THE CAGE WAS THEN IMPACTED INTO THE L3-L4 DISK SPACE UNDER FLUOROSCOPIC GUIDANCE. THE LOCATION OF THE CAGE WAS EXCELLENT IN BOTH SAGITTAL AND CORONAL PLANES.¿ THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241952 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