BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2930981 · Received January 28, 2013

    Report

    Report Number
    1030489-2013-00263
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    SURGERY DATE: (B)(6) 2007 AND (B)(6) 2012. PATIENT INITIALS: (B)(6). GENDER: FEMALE. AGE: (B)(6). IT WAS REPORTED THAT SOMETIME FOLLOWING ANTERIOR CERVICAL SURGERY ON (B)(6) 2007 AND (B)(6) 2012 USING RHBMP-2/ACS THE PATIENT ALLEGEDLY BEGAN TO EXPERIENCE CHANGE IN VOICE,DIFFICULTY SWALLOWING, DIZZINESS, NUMBNESS IN BOTH ARMS, MUSCLE SPASMS, PAIN AND SWELLING IN NECK AND SHOULDERS. ADDITIONAL INFORMATION FROM PT. MEDICAL RECORDS: (B)(6)2009 - PT. PRESENTS FOR OFFICE VISIT. 'PAIN LEVEL HAS INCREASED SINCE THE LAST VISIT.' 'RIGHT SHOULDER PAIN IS WORSENING WITH DECREASED AND PAINFUL RANGE OF MOTION.' ON (B)(6) 2010 - PT. PRESENTS FOR OFFICE VISIT WITH COMPLAINTS OF 'NECK PAIN RADIATING FROM NECK DOWN BOTH ARMS.' 'RIGHT SHOULDER PAIN HAS IMPROVED SINCE INJECTION WITH IMPROVEMENT IN ROM.' ON (B)(6) 2010 - PT. UNDERWENT EXAM FOR CERVICALGIA AND SYNCOPE. ON (B)(6) 2010 - PT. UNDERWENT EXAM FOR ACQUIRED HYPOTHYROID. ON (B)(6) 2010 - PT. UNDERWENT A PROCEDURE FOR TOTAL THYROIDECTOMY. ON (B)(6) 2012 - PT. UNDERWENT SURGERY TO TREAT C6-C7 SPONDYLOSIS, SPINAL STENOSIS, AND NON-UNION OF ANTERIOR CERVICAL FUSION. PROCEDURE WAS FOR C6-C7 BILATERAL LAMINOTOMY, FORAMINOTOMY WITH COMPRESSION OF C7 NERVE ROOTS BILATERALLY, POSTERIOR SPINAL FUSION C6-C7 WITH SPINE 360 LATERAL MASS SEGMENTAL INSTRUMENTATION, LOCAL BONE GRAFT HARVESTING, INFUSE, AND DBX BONE GRAFT EXTENDER. 'THERE WAS A NONUNION AT C6-C7 WITH WHAT APPEARED TO BE A SOLID FUSION AT C5-C6. FORAMINAL STENOSIS BILATERALLY AT C6-C7.' 'LOCALLY HARVESTED BONE WAS PLACED ADJACENT TO DECORTICATED SURFACES OF BONE ON TOP OF THAT WAS PLACED A SMALL INFUSE COLLAGEN SPONGE SOAKED WITH INFUSE BMP AND WITH SOME DBX ALLOGRAFT AND LATERAL GUTTERS ON BOTH SIDES.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37208 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention