BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4152878 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03936
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    October 17, 2016
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: ON (B)(6) 2009, THE PATIENT PRESENTED WITH INTRACTABLE LOW BACK PAIN, DISCOGENIC DISEASE L5-S1, FAILURE OF CONSERVATIVE THERAPY. RIGHT L5 RADICULOPATHY. RIGHT LOWER EXTREMITY PAIN, NUMBNESS AND TINGLING. THE PATIENT UNDERWENT MINIMALLY INVASIVE L4-L5, L5-S1 DISCECTOMIES, TRANSVERSE LUMBAR INTERBODY ARTHRODESIS, PEAK INTERBODY CASE, SUPPLEMENTAL BMP AUTOGRAFT ARTHRODESIS, L4-L5 TO L5-S1. PEDICLE SCREW INSTRUMENTATION L4-S1. LEFT SIDED PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION L4 TO SACRUM. THE INTRA-OP FINDINGS WERE DEGENERATIVE DISK DISEASE AT L5-S1, RIGHT IATROGENIC L4-L5 FACET FRACTURE. AS PER OP NOTES, FASTENED A 12 MM PEAK INTERBODY CAGE WITHIN THE INTERBODY SUPPLEMENTED WITH AUTOGRAFTING TAKEN THE LAMINECTOMY BONE AS WELL AS INCREASED BMP WENT AHEAD AND POSITIONED A 12 MM * 31 MM PEAK INTERBODY CAGE SUPPLEMENTED WITH BMP AS WELL AS AUTOGRAFT IN THE INTERSPACE AFTER GOOD DISCECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION AT L4-5, L5-S1 USING RHBMP-2/ACS. FOLLOWING THE SURGERY, THE PATIENT SUFFERED SIGNIFICANT PAIN IN THE AREA OF THE FUSION SURGERY AND EXTREMITIES. CONSEQUENTLY, THE PATIENT UNDERWENT ADDITIONAL IMAGING THAT SHOWED THAT THE HAD DEVELOPED BONY OVERGROWTH. THE PATIENT HAS RECEIVED SIGNIFICANT MEDICAL TREATMENT TO CARE FOR THE INJURIES CAUSED BY THE ORIGINAL FUSION SURGERY. THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY, AND HE HAS DAILY, DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630417 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 32 YR Other| R