BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2864189 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02734
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 19, 2015
    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)(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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (B)(6).

    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

    PER MEDICAL RECORDS IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT PRESENTED WITH L5-S1 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT: L5-S1 TRANSFORAMINAL INTERBODY FUSION USING PEDICLE SCREW INSTRUMENTATION, PEEK INTERBODY SPACER AND BMP. AS PER OP NOTES, L5-S1 BILATERAL FORAMINOTOMIES WERE PERFORMED. A COMPLETE FACETECTOMY WAS PERFORMED ON THE RIGHT SIDE. THE DISK SPACE WAS IDENTIFIED. A PEEK INTERBODY SPACER WAS PACKED WITH AUTOLOGOUS BONE AND BMP, AND THEN TAMPED INTO PLACE UNDER FLUOROSCOPIC GUIDANCE. PEDICLE SCREWS WERE PLACED BILATERALLY AT L5-S1. BONE COLLECTED FROM THE DECOMPRESSION WAS PACKED INTO BMP-SOAKED SPONGES, AND THESE WERE PLACED OVER THE DECORTICATED LATERAL ELEMENTS BILATERALLY. RODS WERE COUNTERED AND APPLIED TO THE PEDICLE SCREWS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. (B)(6) 2012 THE PATIENT PRESENTED FOR URGENT ESOPHAGOGASTRODUODENOSCOPY. THE PATIENT UNDERWENT ENDOSCOPY. THE PATIENT TOLERATED THE PROCEDURE WELL.

    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 M110710AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other