BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2946282 · Received February 6, 2013

    Report

    Report Number
    1030489-2013-00394
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 7, 2013
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLYSIS AT L5-S1. THE PATIENT UNDERWENT LAMINECTOMY, FACETECTOMY, AND DISCECTOMY AT L5-S1 ON THE LEFT, TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH INTERBODY IMPLANT AND RHBMP-2/ACS AT L4-S1, AND PEDICLE SCREW FIXATION AT L5-S1, WITH IN SITU AUTOGRAFT L5-S1 INTERSPACE. 175 DAYS POST-OP, THE PATIENT PRESENTED STATUS POST FUSION, L5-S1 AND WITH BONY OVERGROWTH WITH S1 NERVE ROOT COMPRESSION. THE PATIENT UNDERWENT LAMINECTOMY AND DECOMPRESSION OF S1 ROOT AND L5 ROOT ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50812 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC M114001AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention