BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3162253 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02152
    Event Type
    Injury
    Date Received
    June 11, 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

    ADD'L INFO.

    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-S1 TLIF AND POSTEROLATERAL FUSION WITH IMPLANT OF RHBMP-2/ACS, INTERBODY CAGE, PEDICLE SCREW INSTRUMENTATION, AND BONE VOID FILLER. 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) 2005: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4-L5 AND L5-S1 DEGENERATIVE DISC DISEASE, L5-S1 LATERAL RECESS STENOSIS AND UNDERWENT THE FOLLOWING PROCEDURES: L4-L5 AND L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSIONS WITH CAGES AND BONE MORPHOGENIC PROTEIN. RIGHT L4-L5 AND L5-S1 MINIMALLY INVASIVE TUBULAR RETRACTION POSTEROLATERAL FUSION WITH BONE MORPHOGENIC PROTEIN. L4 TO S1 POSTERIOR SEGMENTAL INSTRUMENTATION WITH PERCUTANEOUS PEDICLE SCREWS AND RODS. AS PER OP-NOTES, "A SMALL PORTION OF BONE MORPHOGENIC PROTEIN SPONGE BONE GRAFT WAS INSERTED AND THE TUBULAR RETRACTOR WAS DIRECTED TO THE L5-S1 FACET. THE DISC SPACE WAS SEQUENTIALLY DILATED WITH INTERBODY TRIALS AND THEN TIGHTENED DOWN ON THE S1 SCREW TO MAINTAIN THE DISTRACTION. BONE MORPHOGENIC PROTEIN SPONGES AND BONE GRAFT WERE PACKED INTO THE DISC SPACE. A 12 MM X 26 MM CAGE WAS SELECTED AS THE IMPLANT. A BONE MORPHOGENIC PROTEIN SPONGE WAS PLACED INTO IT. THEN I TIGHTENED DOWN THE L5 SET SCREW TO MAINTAIN THE DISTRACTION. THE END PLATES WERE THEN METICULOUSLY PREPARED TO ACCEPT AN IMPLANT. A 12 MM X 32 MM IMPLANT WAS SELECTED. BONE MORPHOGENIC PROTEIN SPONGES AND BONE GRAFT WERE PACKED INTO THE DISC SPACE AND ADDITIONAL BONE MORPHOGENIC PROTEIN SPONGE PLACED INTO THE IMPLANT, WHICH WAS INSERTED INTO THE DISC SPACE." THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2006: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH STATUS EPILEPTICUS, POSSIBLE ENCEPHALITIS OR VASCULITIS AND UNDERWENT THE FOLLOWING PROCEDURES: LEFT TEMPORAL CRANIOTOMY AND BRAIN AND DURAL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262097 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 00054 YR Required Intervention