BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3117807 · Received May 17, 2013

    Report

    Report Number
    1030489-2013-01731
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 18, 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

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BACK PAIN L4-S1 DIST, RADICULOPATHY AND EXTREMITY PAIN. THE PATIENT WAS DIAGNOSED WITH SPONDYLOLISTHESIS L5-S1, SCOLIOSIS L5-S1. THE PATIENT UNDERWENT AN OPEN ANTERIOR INTERBODY FUSION L4-S1. RHBMP-2/ACS AND ANTERIOR INSTRUMENTATION WEREUSED. LOCAL ANTIBIOTICS WERE APPLIED AND X-RAY VERIFICATION OF LEVELS WAS DONE. THE PATIENT WAS DISCHARGED HOME. THE PATIENT'S 30-DAY ODI WAS 30. THE PATIENT DEVELOPED ATRIAL ARRHYTHMIA POST-OP, AND A SURGICAL SITE INFECTION POST-DISCHARGE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED FOR 30-DAY FOLLOW-UP AND HIS NRS WAS 2. THE PATIENT PRESENTED FOR 6 MONTH FOLLOW-UP AND HIS NRS WAS 2 AND ODI WAS 29. THE PATIENT PRESENTED FOR 1 YEAR FOLLOW-UP AND HIS NRS WAS 1 AND ODI WAS 36. THE PATIENT PRESENTED FOR 2 YEAR FOLLOW-UP AND HIS NRS WAS 3, NRS EXTREMITY WAS 1 AND ODI WAS 17.77777778.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219401 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 00066 YR Required Intervention