BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3117753 · Received May 17, 2013

    Report

    Report Number
    1030489-2013-01724
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    July 14, 2015
    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.

    Description of Event or Problem · 1

    IMPLANT DATE: 2012. PT DEMOGRAPHICS: ID (B)(6), MALE, ETHNICITY: WHITE, FORMER SMOKER (>1 MONTH), HYPERTENSION. FAILED CONSERVATIVE TREATMENT. PREVIOUS SURGERY L2-L5, PREVIOUS CERVICAL SURGERY. CONCOMMITANT MEDICATIONS INCLUDE ACE OR ARB INHIBITORS, HYPERTENSION MEDICATIONS. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RADICULOPATHY AND EXTREMITY PAIN. THE PATIENT WAS DIAGNOSED WITH DEGENERATIVE DISC DISEASE L2-L5, BACK PAIN L2 DISTRIBUTION, STENOSIS L2-3, AND SPONDYLOSIS L2-5. PRE-OP ODI 44. THE PATIENT UNDERWENT AN OPEN POSTERIOR SURGERY CONSISTING OF FUSION L3-L5 WITH LAMINOTOMY FACETECTOMY L2-L5. AUTOLOGOUS LOCAL BONE, RHBMP-2/ACS, POSTERIOR INSTRUMENTATION, AND BONE MARROW ASPIRATE WERE USED. LOCAL ANTIBIOTICS WERE APPLIED AND X-RAY VERIFICATION OF LEVELS WAS DONE. THE PATIENT WAS DISCHARGED HOME. THE PATIENT REQUIRED A "SERIMA" DRAINAGE PROCEDURE POST-OP, AND PERCUTANEOUS DRAIN. PATIENT ADDITIONALLY DEVELOPED HYPERTENSION POST-OP.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT POSTERIOR LAMINECTOMY AT L2-L3. THE PATIENT PRESENTED FOR A 30 DAY FOLLOW-UP AND HIS NRS WAS 2 AND ODI WAS 30. THE PATIENT PRESENTED FOR A 6 MONTH FOLLOW-UP AND HIS NRS BACK WAS 2 AND ODI WAS 29. THE PATIENT PRESENTED FOR A 1 YEAR FOLLOW-UP AND HIS NRS WAS 1 AND ODI WAS 36. THE PATIENT PRESENTED FOR A 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
    218875 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 00071 YR Required Intervention