BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862204 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02682
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    May 22, 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)(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) 2004, THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS, L4-5, L5-S1; IN CAPACITATING BACK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURE: REVISION LUMBAR FUSION, L4-5, L5-S1; REVISION INSTRUMENTATION WITH PARTIAL REPLACEMENT OF INSTRUMENTATION; ILIAC CREST BONE GRAFT; AUGMENTATION WITH RHBMP-2. AS PER OP-NOTES,¿ AFTER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA WAS OBTAINED, THE PATIENT WAS POSITIONED PRONE ON THE WILSON FRAME. THE BACK WAS PREPPED AND DRAPED IN ROUTINE FASHION. A LOW LUMBAR INCISION WAS MADE. THE DISSECTION WAS CARRIED LATERALLY, AND THE METAL WAS EXPOSED LATERALLY. THE DISSECTION WAS THEN CARRIED OVER THE METAL ONTO THE TRANSVERSE PROCESS. THE BONE GRAFT WHICH HAD PREVIOUSLY BEEN PLACED HAD NOT FUSED. THE METAL WAS LOOSENED. THERE WAS CLEARLY MOTION BETWEEN L5-S1 AND L4-5. THE METAL WAS REMOVED WITH THE EXCEPTION OF THE SCREWS AT L4 AND L5 BILATERALLY. ON THE RIGHT SIDE, AN 8 MM SCREW WAS PLACED. ON THE LEFT SIDE, A 7 MM SCREW WAS PLACED AT S. THESE ACHIEVED GOOD INTERFERENCE FIT. AN OBLIQUE INCISION WAS MADE OVER THE LEFT ILIAC CREST. THE OUTER TABLE WAS EXPOSED. STRIPS OF CORTICOCANCELLOUS AND CANCELLOUS GRAFT WERE THEN TAKEN. THE GRAFT SITE WAS THEN PACKED WITH GELFOAM. THE FASCIA WAS CLOSED OVER THE DRAIN. THE WOUND WAS CLOSED IN ROUTINE FASHION.¿ 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| R