BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3963779 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03332
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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. 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 UNDERWENT A FUSION SURGERY ON THE LUMBAR REGION OF HIS SPINE FROM L4 TO S1 SPINAL FUSION SURGERY ON (B)(6) 2010 USING RHBMP-2/ACS. THE PATIENT REPORTEDLY EXPERIENCED TWO MONTHS OF INITIAL RELIEF, FOLLOWED BY SCIATIC PAIN, LEFT SIDED RADICULAR SYMPTOMS, AND LOWER BACK NUMBNESS. ON (B)(6) 2013, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE OVERGROWN BONE FROM THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440756 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 Required Intervention