BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171061 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02303
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 28, 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

    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.

    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 A PROCEDURE FOR LATERAL/POSTEROLATERAL FUSION WHERE RHBMP-2 WAS MIXED WITH BONE VOID FILLER AND TRICALCIUM PHOSPHATE AND IMPLANTED WITH A PEEK CAGE. 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) 2011 THE PATIENT UNDERWENT A DIRECT LATERAL INTERBODY FUSION AT L4-5. PLACEMENT OD INTERBODY CAGE AT L4-5. POSTEROLATERAL FUSION AT L4-5. POSTERIOR INSTRUMENTATION AT L4-5. POSTERIOR INSTRUMENTATION AT L4 TO L5 WITH SCREW INSTRUMENTATION. USE OF BONE MORPHOGENIC PROTEIN. USE OF LOCAL BONE GRAFT AND BONE GRAFT. PREOPERATIVE DIAGNOSIS: DEGENERATIVE DISEASE, L4-5. SPINAL STENOSIS, L4-5. POST-LAMINECTOMY SYNDROME, L4-5. PER-OP NOTES: ¿THE GRAFT WAS OF SIZE 45X10, WITH LORDOSIS. IT WAS FILLED WITH A COMBINATION OF BONE GRAFT, TRICALCIUM PHOSPHATE AND BMP-SOAKED COLLAGEN SPONGES. THIS ASSEMBLY WAS THEN INSERTED IN THE L4-5 DISTRIBUTION UNDER FLUOROSCOPIC GUIDANCE WITHOUT DIFFICULTY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270601 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention