BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2861386 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02636
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    July 31, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PREVIOUS ANTERIOR L4-L5 FUSION WITH PSEUDOARTHROSIS, LOW BACK PAIN WITH BILATERAL LUMBAR RADICULOPATHY, ISTHMIC SPONDYLOLISTHESIS, L4-L5, TRANSITIONAL ANATOMY AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR RETROPERITONEAL EXPOSURE OF L4-5, MOBILIZATION OF ILIAC VESSELS, HARDWARE REMOVAL, EXPLORATION AND REPAIR OF INTERBODY FUSIO N/PSEUDOARTHROSIS WITH DEMINERALIZED BONE MATRIX, RHBMP-2 (BONE MORPHOGENIC PROTEIN). GILL LAMINECTOMIES, L4-5, MEDIAL FORAMINOTOMIES. POSTEROLATERAL FUSION,L4-5,WITH PEDICLE SCREW INSTRUMENTATION, DEMINERALIZED BONE MATRIX, LOCAL AUTOLOGOUS MORSELIZED BONE GRAFT, RHBMP-2 BONE MORPHOGENIC PROTEIN. AS PER OP-NOTES,¿ RH-BMP 2 WAS USED IN THE SURGERY¿. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    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.

    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