BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163353 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02205
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    September 12, 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

    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) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS. SPONDYLOLISTHESIS L3-L4 AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION L3 THROUGH L4. POSTERIOR SPINAL INSTRUMENTATION L3 THROUGH L4. POSTEROLATERAL FUSION L3-L4. BILATERAL HERMILAMINOTOMIES L3-L4. USE OF OPERATING MICROSCOPE FOR MICROSURGICAL DECOMPRESSION. USE OF BONE MORPHOGENIC PROTEIN FOR POSTEROLATERAL FUSION. AS PER OP-NOTES, ¿I TOOK THE AUTOGRAFT FROM THE MEDIAL FACETECTOMY AS WELL AS FROM THE SEPARATE FASCIAL INCISION AND THIS MORSELIZED AUTOGRAFT WAS PACKED INTO THE L3-L4 FACET ON THE LEFTALONG WITH ONE HALF BONE MORPHOGENIC PROTEIN SPONGE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2012: THE PATIENT WAS ASSESSED WITH HERNIATED LUMBAR DISC, LOWER BACK PAIN, LUMBAR FACET SYNDROME, LUMBAR RADICULOPATHY AND TROCHANTERIC BURSITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L3-4 FUSION WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND IMPLANTED POSTEROLATERALLY. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264089 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110813AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention