BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3180523 · Received June 20, 2013

    Report

    Report Number
    1030489-2013-02439
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    August 29, 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 L5-S1 TLIF WHERE RHBMP-2 WAS IMPLANTED WITH ALLOGRAFT AND AUTOGRAFT. 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) 2006: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH RECURRENT DISC HERNIATION, L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: L5 BILATERAL LAMINECTOMIES WITH FORAMINOTOMIES, LEFT PARIETAL MEDICAL FACETECTOMY AND RIGHT COMPLETE INFERIOR FACETECTOMY. TRANSFORAMINAL LUMBAR INTERBODY FUSION, L5-S1. PEAK INTERBODY FUSION CAGE, L5-S1. BONE MORPHOGENIC PROTEIN SPONGE PREPARATION AND APPLICATION. POSTERIOR SPINAL INSTRUMENTATION WITH SHORT-POST SCREW-ROD CONSTRUCT WITH CROSS-LINK. MORCELLIZED AUTOGRAFT BONE GRAFT. MORCELLIZED ALLOGRAFT BONE GRAFT. AS PER OP-NOTES, "... A LARGE BMP SET WAS MIXED AND ALLOWED TO SIT FOR 30 MINUTES. THE SIX SPONGES WERE ROLLED TIGHTLY AND IMPACTED INTO THE L5-S1 PREPARED DISC SPACE, WITH THE END PLATES BEING PUNCTUATE WITH HEALTHY BLEEDING BONE. THE PEAK INTERBODY FUSION CAGE WAS CHOSEN, WHICH WAS 10 X 26 IN LENGTH. THE CAGE WAS FILLED WITH MORCELLIZED AUTOGENOUS BONE GRAFT AND THIS WAS IMPACTED INTO THE INTERSPACE THROUGH THE TRANSFORAMINAL APPROACH TO SEAL OFF THE INTERSPACE FROM BMP. ADDITIONAL MORCELLIZED AUTOGRAFT BONE GRAFT PRODUCTS OF DECOMPRESSION WERE PLACED AROUND THE CAGE FOR ADDITIONAL BONE FOR FUSION. NEXT 6.5 MM SHORT-POST SCREWS WERE PLACED THROUGH THE PEDICLES AND INTO THE VERTEBRAL BODIES BILATERALLY AT L5 AND 7.5MM SHORT-POST SCREWS AT S1. THE 5.5 MM RODS WERE PLACED WITH 3D CONNECTORS AND A CROSS-LINK PLACED DISTALLY TO LOCK THE RODS TOGETHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281150 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 00053 YR Required Intervention