BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2840011 · Received November 20, 2012

    Report

    Report Number
    1030489-2012-02389
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    May 9, 2018
    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)(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 THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: RIGHT C7 RADICULOPATHY SECONDARY TO RIGHT SIDED C6-7 DISC HERNIATION; CERVICAL SPINAL STENOSIS AT C5-6 AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY AND FUSION C5-6 AND C6-7. ANTERIOR OSTEOPHYTECTOMY AT C5-6 AND C6-7 FUSION WITH 5MM COURSE ON ALLOGRAFT SUPPLEMENTED WITH BMP AT C5-6 AND 8MM CORNERSTONE ALLOGRAFT SUPPLEMENTED WITH BMP AT C6-7. INTERNAL FIXATION WITH 47.5MM ATLANTIS PLATE AND TWO 15MM VARIABLE SCREWS IN THE C5 VERTEBRAL BODY AND FOUR 16MM VARIABLE SCREWS IN THE C6 AND C7 VERTEBRAL BODY. AS PER OP-NOTES,¿ ATTENTION WAS THEN DIRECTED TO THE C5-6 DISC SPACE WHICH WAS PLACED UNDER DISTRACTION WITH CASPAR PINS WITH COMPLETE C5-6 ANTERIOR DISCECTOMY WAS PERFORMED AND ANTERIOR OSTEOPHYTECTOMY AND FORAMINOTOMY WAS PERFORMED OVER THE RIGHT C6 NERVE ROOT. CORPUS OF C5 AND C6 WAS THEN PREPARED FOR THE FUSION WITH HIGH SPEED DRILL. A 5MM CORNERSTONE ALLOGRAFT WAS SUPPLEMENTED WITH BMP AND PLACED IN THE DISC SPACE AT C5-6. IT WAS THOUGHT THAT WE HAD EXCELLENT FIT WITH THIS BONE GRAFT AS WELL.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. (B)(6) 20007: THE PATIENT WAS DISCHARGED FROM THE FACILITY.

    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