BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163334 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02193
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 21, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L3-L5 FUSION WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND ALLOGRAFT, AND IMPLANTED 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) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L4-L5 SPONDYLOLISTHESIS. SPINAL STENOSIS. LOW BACK PAIN. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTEROLATERAL FUSION L3-L4. POSTEROLATERAL FUSION L4-L5. POSTERIOR LUMBAR INTERBODY FUSION L4-L5. L4 LAMINECTOMY. L5 HEMILAMINECTOMY. PLACEMENT OF PROSTHETIC INTRAVERTEBRAL DEVICE L4-L5 (9 X 22MM X 8 CAGE). POSTERIOR SPINAL INSTRUMENTATION L3-L5 WITH 5.2 X 45 MM SCREWS AT L3, 6.2 X 40 MM SCREW ON THE LEFT AT L4, 6.2 X 45 MM SCREW ON THE RIGHT AT L4 (REDUCTION SCREWS), 6.5 X 45 MM SCREW ON THE LEFT AT L5, AND 6.2 X 50 MM SCREW ON THE RIGHT AT L5. L4-L5 REDUCTION. USE OF LOCAL BONE. USE OF CORTICOCANCELLOUS ALLOGRAFT. USE OF BONE MORPHOGENIC PROTEIN. PER OP NOTES: "AT L4-L5 DISK SPACE, AN AMPLE AMOUNT OF ALLOGRAFT AUGMENTED WITH LOCAL BONE WAS PLACED BILATERALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264561 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110812AAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention