BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3162218 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02151
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    August 15, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT AN ANTERIOR L4-S1 FUSION WITH IMPLANT OF RHBMP-2 AT MULTIPLE LEVELS. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION L4-5 AND L5-S1 USING PEEK INTERBODY GRAFT WITH BMP AND ANTERIOR PLATE FIXATION AT EACH LEVEL. ON (B)(6) 2008, PATIENT PRESENTED FOR 3 WEEKS FOLLOW-UP POST ANTERIOR LUMBAR INTERBODY FUSION. PATIENT REPORTED ANTERIOR THIGH PAIN AFTER PROLONGED WALKING. AP AND LATERAL LUMBAR FILMS REVEALED IMPLANTS AND INSTRUMENTATION VISIBLE WELL AND WELL POSITIONED AT L4-5 AND L5-S1. ON (B)(6) 2008, PATIENT PRESENTED FOR SIX WEEKS FOLLOW-UP POST ANTERIOR LUMBAR INTERBODY FUSION. PATIENT REPORTED SOME LOW BACK PAIN. X-RAYS SHOWED AP AND LATERAL VIEWS OF THE LUMBAR SPINE REVEALED L4-5 AND L5-S1 GRAFTS WERE HEALING. ON (B)(6) 2008, PATIENT PRESENTED FOR 12 WEEKS FOLLOW-UP POST ANTERIOR LUMBAR INTERBODY FUSION. PATIENT REPORTED OCCASIONAL PAIN IN RIGHT LATERAL HIP AND THIGH, WHICH WORSENS AFTER ACTIVITY. AP AND LATERAL LUMBAR FILMS REVEALED IMPLANTS AND INSTRUMENTATION VISIBLE WELL AND WELL POSITIONED AT L4-5 AND L5-S1. ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW-UP VISIT. PATIENT REPORTED SIGNIFICANT DISCOMFORT IN SHOULDER. MRI FORM (B)(6) 2007 SHOWED NO OBVIOUS ROTATOR CUFF TEAR. ON (B)(6) 2009, PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINT OF LOWER BACK PAIN AND BILATERAL LOWER EXTREMITIES SYMPTOMS AFTER DRIVING RECENTLY. HE ALSO REPORTED INCREASE IN PAIN AFTER WALKING. X-RAYS SHOWED WELL HEALED FUSION. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW-UP VISIT FOR EVALUATION OF MRI ANTHROGRAM OF RIGHT SHOULDER. MRI SHOWED A PARTIAL ROTATOR CUFF TEAR. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW UP 5 MONTHS POST-OP. PATIENT REPORTED RIGHT LOW BACK PAIN AND INTERMITTENT RIGHT LEG PAIN AND RIGHT GROIN PAIN. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW-UP VISIT FOR SHOULDER PAIN. PATIENT REPORTED NIGHT PAIN AND PAIN WITH OVERHEAD ACTIVITY; AND WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262817 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110705AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention