BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171125 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02308
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 11, 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

    (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 PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: SPONDYLOLYSIS L5, BILATERAL. GRADE 1 SPONDYLOLISTHESIS, L5-S1. MECHANICAL LOW BACK PAIN. 4. LEFT LUMBAR NERVE ROOT IRRITATION. LEFT LUMBAR RADICULOPATHY. HE UNDERWENT FOLLOWING PROCEDURES: POSTERIOLATERAL FUSION, L5 TO S1, UTILIZING AUTOLOGOUS ILIAC CREST BONE GRAFT SUPPLEMENTED WITH SMALL SIZE KIT OF BONE MORPHOGENIC PROTEIN BILATERAL HEMILAMINOTOMIES, L4-5. 3. BILATERAL HEMILAMINOTOMIES, L5-S1. AS PER OPERATIVE NOTES, ¿LEFT POSTERIOR ILIAC CREST BONE GRAFT. THIS WAS DONE THROUGH THE SAME SKIN INCISION, BUT THROUGH A SEPARATE FASCIAL INCISION. THE UNDERLYING BONE WAS EXPOSED STRAIGHT AND ANGLED OSTEOTOMES AND CURETTES WERE UTILIZED TO HARVEST BONE AND THIS WAS MORSELIZED ANDUTILIZED FOR THE FUSION. THE DECORTICATED AREAS WERE CAREFULLY PREPARED FOR BONE GRAFTING. THIS BONE MORPHOGENIC PROTEIN WAS PLACED INTO THE CARRIER SPONGE AND ALLOWED TO SIT. IT WAS THEN CHOPPED UP INTO SMALL SQUARES, INTRODUCED INTO THE BONE GRAFT, AND MIXED IN AND THEN CAREFULLY PLACED INTO THE LATERAL GUTTERS, ACCOMPLISHING THE FUSION GRAFTING FROM L5 TO S1.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270948 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