BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6295693 · Received February 2, 2017

    Report

    Report Number
    1030489-2017-00188
    Event Type
    Injury
    Date Received
    February 2, 2017
    Report Date
    January 9, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    UDI-DI
    00681490843829
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH IT IS UNKNOWN IF THE DEVICE 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) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS, L5-S1 AND UNDERWENT 360 DEGREE FUSION VIA POSTERIOR O NLY APPROACH (TRANSFORAMINAL LUMBAR INTERBODY FUSION). AS PER OP-NOTES, ¿THE END-PLATES WERE PREPARED, THE WOUND IRRIGATED, DISTRACTION APPLIED WITH A SCISSOR JACK, AND THE DISK SPACE WAS SIZED FOR CAGE. IT WAS SIZED TO A 13 MILLIMETER CAGE. THE ANTERIOR ASPECT OF THE DISK SPACE WAS PACKED WITH A COMBINATION OF BONE GRAFT MATRIX AND RHBMP-2/ACS. THE CAGE WAS PACKED WITH MORSELIZED BONE AND IMPACTED INTO THE DISK SPACE WITH GOOD FIT AND FIXATION. LATERAL GUTTER ON THE RIGHT WAS PACKED WITH A COMBINATION OF LOCAL BONE AND RHBMP-2/ACS; ON THE CONTRALATERAL SIDE WITH BONE GRAFT MATRIX ONLY. ON AN UNKNOWN DATE POST-OP, PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80398 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110614AAL 00681490843829

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other