BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3080769 · Received April 26, 2013

    Report

    Report Number
    1030489-2013-01336
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: 2012. (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 NECK/BACK PAIN, RADICULOPATHY, AND DIMINISHED REFLEX. SHE WAS DIAGNOSED WITH SINGLE LEVEL DEGENERATIVE DISC DISEASE, L4-5, 50% LISTHESIS L4-5 AND L4-5 STENOSIS. THE PATIENT UNDERWENT OPEN 360 LUMBAR INSTRUMENTED FUSION L4-5, POSTERIOR LAMINOTOMY USING ALLOGRAFT, RHBMP-2/ACS, POSTERIOR INSTRUMENTATION, INTERBODY CAGE, NEUROLOGICAL MONITORING, AND X-RAY VERIFICATION OF THE LEVEL. THERE WERE NO NOTED COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME THE PATIENT'S 30-DAY NRS SCORE WAS 5. THE PATIENT'S 30-DAY ODI SCORE WAS 62. POST- DISCHARGE, THE PATIENT HAD AN UNSPECIFIED EVENT, AND UNDERWENT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181024 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 00054 YR Required Intervention