BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2950602 · Received February 8, 2013

    Report

    Report Number
    1030489-2013-00432
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    December 28, 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

    DATE OF IMPLANT: (B)(6) 2010 AND/OR (B)(6) 2011. (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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 ON: (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4-5 DISCOGENIC BACK PAIN AND UNDERWENT THE FOLLOWING PROCEDURE: L4-5 DE COMPRESSIVE LAMINECTOMY, FACETECTOMY AND FORAMINOTOMY WITH L4-5 TLIF, L4-5 CAGE APPLICATION, AUTOGRAFT, ALLOGRAFT, L4-5 POSTEROLATERAL ARTHRODESIS WITH L4-5 POSTERIOR NON-SEGMENTAL INSTRUMENTATION, STEALTH IMAGE GUIDANCE AND INTRAOPERATIVE FLUOROSCOPY. AS PER OP-NOTES,¿ THE CARTILAGINOUS ENDPLATE WAS REMOVED AND THE BONY ENDPLATE WAS ROUGHED UP DOWN TO BLEEDING BONE. THE DISC SPACE WAS IRRIGATED AND TRIALS WERE PLACED. A 14 X 26MM CAGE WAS THE BEST FIT. A RHBMP2 SPONGE WAS THEN PLACED IN THE ANTERIOR DISC SPACE AND THEN RHBMP2 AND AUTOGRAFT WERE PACKED INSIDE OF A 14X 26 PEEK CAGE. THE CAGE WAS PUT INTO PLACE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54030 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110905AAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R