BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171018 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02300
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-L5 AND L5-S1 FUSION WHERE RHBMP-2 WAS MIXED WITH LAMINA BONE AND BONE VOID FILLER, AND PLACED INTO THE SPINE AT EACH LEVEL VIA A POSTERIOR APPROACH. 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: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR STENOSIS WITH LUMBAR EPIDURAL LIPOMATOSIS, SPONDYLOLISTHESIS AND DEGENERATIVE DISK DISEASE AND UNDERWENT THE FOLLOWING PROCEDURES: L4 LAMINECTOMY, BILATERAL FACETECTOMY L4-5. L5 LAMINECTOMY, BILATERAL FACETECTOMY L5-S1. PEDICLE SCREW FIXATION L4-5, S1, TRANSVERSE PROCESS FUSION L4-5, S1 USING BMP, MORSELIZED LAMINA BONE, BONE GRAFT. NIMS MONITORING SYSTEM BILATERAL EXTREMITIES. USE OF O-ARM GUIDED CT STEALTH FOR SCREW PLACEMENT. AS PER OP-NOTES, ¿WE PLACED BMP, MORSELIZED LAMINA BONE, BONE GRAFT, PERFORMED BILATERAL TRANSVERSE PROCESS FUSION L4-L5, S1.¿ THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271451 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 00050 YR Required Intervention