BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2863226 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02696
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 15, 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

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

    Additional Manufacturer Narrative · 1

    (B)(6). (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 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) 2010: THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS IMPLANTED. AS PER OP-NOTES,¿ AN ANNULOTOMY WAS PERFORMED ON THE LEFT SIDE. THE DISK SPACE WAS THEN EVACUATED WITH VARIOUS ENDPLATE SCRAPERS, SHAVERS AND CURETTES. THE ENDPLATES WERE THEN PREPARED FOR FUSION. THE INTERSPACE WAS SIZED TO A 13 MM IMPLANT WHICH WAS SELECTED AND FILLED WITH A BMP SPONGE AND A DIFFERENT BMP SPONGE AND SOME MORSELIZED BONE FROM THE DECOMPRESSION WAS THEN PLACED INTO THE DISK SPACE. THEN THE INTERBODY DEVICE WAS IMPACTED INTO THE DISK SPACE AND TURNED INTO A TRANSVERSE POSITION. THE DISTRACTION WAS REMOVED.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other