BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190929 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02538
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 17, 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    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.

    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 THAT THE PATIENT UNDERWENT A BILATERAL POSTERIOR APPROACH L4-L5 FUSION USING "IMPROPER HARDWARE" AND RHBMP-2/ACS MIXED WITH AUTOGRAFT, ALLOGRAFT AND DEMINERALIZED BONE MATRIX. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LUMBAR SPINAL STENOSIS WITH NEUROGENIC CLAUDICATION AND L4-L5 SPONDY LOLISTHESIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: BILATERAL LAMINECTOMY AT L3, L4, L5 AND S1; BI-PEDICULAR SCREW FIXATION AT L4, L5; BILATERAL INTER-TRANSVERSE PROCESS ARTHRODESIS AT L4-L5, BILATERAL INTER-TRANSVERSE PROCESS BONE MORPHOGENIC PROTEIN AT L4-L5 LOCAL MORCELLIZED BONE GRAFT, BILATERAL POSTERIOR LUMBAR INTERBODY ARTHRODESIS AT L4-L5, BILATERAL STRUCTURAL INTERBODY ALLOGRAFT AT L4-L5, BILATERAL BONE MORPHOGENIC PROTEIN INTERBODY FUSION AT L4-L5. PER OP NOTES, BILATERAL POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED USING BMP AND STRUCTURAL INTERBODY ALLOGRAFT. AN INTER-TRANSVERSE PROCESS ARTHRODESIS WAS PERFORMED USING BMP, LOCALIZED MORCELLIZED BONE GRAFT AND DEMINERALIZED BONE MATRIX. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290922 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M114001AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention