BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3080691 · Received April 26, 2013

    Report

    Report Number
    1030489-2013-01334
    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

    (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 RADICULOPATHY AND EXTREMITY PAIN. THE PATIENT WAS DIAGNOSED WITH BACK PAIN L4-S2, POST LAMINECTOMY FAILED BACK L4-S2, PSEUDOARTHROSIS L5-S2, DEGENERATIVE DISC DISEASE L4-5. THE PATIENT UNDERWENT AN OPEN POSTERIOR SURGERY CONSISTING OF REVISION SURGERY L4-S2, DISCECTOMY L4-5, LUMBAR POSTERIOR INTERBODY INSTRUMENTED FUSION L4-S2, LAMINECTOMY L4-S2, LAMINOTOMY L4-5. AUTOLOGOUS LOCAL BONE, RHBMP-2/ACS, POSTERIOR INSTRUMENTATION, AND CALCIUM-BASED BONE GRAFT SUBSTITUTES WERE USED. LOCAL ANTIBIOTICS WERE APPLIED AND X-RAY VERIFICATION OF LEVELS WAS DONE. THE PATIENT WAS DISCHARGED HOME. THE PATIENT'S 30-DAY NRS WAS 6. THE PATIENT'S 30-DAY ODI WAS 66. THE PATIENT HAD HARDWARE FAILURE POST-DISCHARGE AND NEUROLOGICAL DEFICIT POST-DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182563 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 00056 YR Required Intervention