BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192992 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02583
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    September 26, 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

    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 AN ANTERIOR L3-S1 FUSION USING A PEEK SPACER AND RHBMP-2/ACS MIXED WITH ALLOGRAFT. PATIENT WAS DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT INCLUDING AN ADDITIONAL SURGERY ON (B)(6) 2014. 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) 2011: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L3-S1 STENOSIS/ SPONDYLOLISTHESIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: L3-S1 ANTERIOR LUMBAR INTERBODY FUSION; L3-S1 INTERBODY GRAFT PLACEMENT; L3-S1 INSTRUMENTATION; USE OF ALLOGRAFT CHIPS AND BONE MORPHOGENIC PROTEIN. INSTRUMENTATION: SYNTHES PEEK INTERBODY CAGES, WITH BUTTRESS SCREW AND WASHER. PER OP- NOTES, " ..A SIZE 15 MM TRIAL WAS SEEN APPROPRIATE AND WAS OPENED AND ALLOGRAFT CHIPS, AND ONE THIRD OF A LARGE BMP WAS PLACED WITHIN THE PEEK SPACER. THE GRAFT WAS MALLETED INTO SPACE, UNDER LATERAL FLUOROSCOPY, AND SEEN TO BE SEEN IN GOOD POSITION. AT THIS POINT, THE L4-L5 AND L5-S1 DISKECTOMY AND FUSIONS WERE COMPLETED IN SIMILAR FASHION..". PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2011: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L3 SCREW LOOSENING. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: BILATERAL L3 HARDWARE REMOVAL; L3-S1 INSPECTION OF FUSION; L1-L3 POSTERIOR SPINAL FUSION; L1-L3 INSTRUMENTATION; USE OF LOCAL BONE GRAFT; USE OF ALLOGRAFT CHIPS AND DBM; USE OF INTRAOPERATIVE AND NEUROPHYSIOLOGIC MONITORING. PER OP NOTES, BILATERAL RODS WERE REMOVED AFTER REMOVING ALL THE NUTS AND BILATERAL L3 SCREWS WERE SEEN TO BE COMPLETELY LOOSE. AT THIS POINT DECISION WAS MADE TO EXTEND FUSION TO L1 DUE TO THE LACK OF STABILITY AT L3, PATIENT¿S COMORBIDITIES INCLUDING OBESITY, SMOKING, AND DIABETES TO GIVE FURTHER STABILITY TO L1. .. FINAL FLUOROSCOPY REVEALED GOOD PLACEMENT OF INSTRUMENTATION. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294006 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110916AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention