BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3061394 · Received April 16, 2013

    Report

    Report Number
    1030489-2013-01052
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 1, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION ON THE LEVELS L4-S1. HE WAS IMPLANTED WITH RHBMP-2/ACS. POST SURGERY, THE PATIENT HAD PROGRESSIVELY WORSENING PAIN IN HIS LOW BACK, WITH ASSOCIATED RADICULOPATHY AND SPASMS IN HIS LOWER EXTREMITIES. THE PATIENT CONTINUES TO EXPERIENCE CHRONIC BACK PAIN, WITH ASSOCIATED RADICULOPATHY AND PAIN IN HIS LOWER EXTREMITIES. HE ALSO EXPERIENCES URINARY, BOWEL AND SEXUAL ISSUES. HE CANNOT SIT, STAND OR WALK FOR EXTENDED PERIODS. HE IS UNABLE TO ENJOY HIS DAILY ACTIVITIES THAT HE ENJOYED PRE-OPERATIVELY, AND HAS SUFFERED SERIOUS AND PERMANENT INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2004: PATIENT GOT ADMITTED WITH PRE-OP DIAGNOSIS: LEFT L5-S1 HERNIATED DISC. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LEFT L5-S1 MICROLUMBAR DISCECTOMY WITH MICROSCOPIC DISSECTION OF THE VESSEL AND THE NERVE ROOT. ON (B)(6) 2004: PATIENT WHO HAD HISTORY OF BACK PAIN AND RADICULOPATHY, GOT ADMITTED WITH PRE-OP DIAGNOSIS: L4-5 DISC HERNIATION. PATIENT UNDERWENT THE FOLLOWING PROCEDURE: L4-5 MICROLUMBAR DISCECTOMY AND MICROSCOPIC DISSECTION OF TRAVERSING L5 NERVE ROOT. ON (B)(6) 2004: PATIENT GOT DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2006: PATIENT GOT ADMITTED WITH PRE-OP DIAGNOSIS: RECURRENT HERNIATED DISCS, L4-L5 AND L5-S1, DEGENERATIVE DISC DISEASE, L4-L5 AND L5-S1. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LEFT RE-EXPLORATION AND DECOMPRESSIVE MICRODISKECTOMIES, L4-L5 AND L5-S1, APPROACHING FROM THE LEFT SIDE. TRANSFORAMINAL INTERBODY FUSION, ARTHRODESIS AND INTER-BODY CAGE USING MINIMALLY INVASIVE METRX SYSTEM, BONE MORPHOGENIC PROTEIN (BMP), CAGES. PERCUTANEOUS PEDICLE SCREW FIXATION AND FUSION, L4, L5 AND S1. PER OP-NOTES: "BONE THAT WAS SAVED FROM FUSION WAS THEN PLACED INTO THE DISC SPACE ALONG WITH EXTRA BONE MORPHOGENIC PROTEIN (BMP). A 14 MM CAGE FILLED WITH BMP WAS THEN INSERTED OBLIQUELY TO COVER THE ENTIRE DISC SPACE... AGAIN, ONCE THE ARTHRODESIS HAD BEEN ACCOMPLISHED. THE BONE THAT WAS SAVED WAS PLACED ANTERIORLY ALONG WITH BONE MORPHOGENIC PROTEIN (BMP). AT THE L4-L5 LEVEL, A 12 MM CAGE WAS THEN INSERTED OBLIQUELY FILLED WITH BONE MORPHOGENIC PROTEIN (BMP)." ON (B)(6) 2006: PATIENT WHO IS 16 DAYS POST A MINIMALLY INVASIVE L4-L5, L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION, PRESENTED FOR FOLLOW UP VISIT. ON (B)(6) 2006: PATIENT PRESENTED FOR HIS SECOND POST-OPERATIVE VISIT. PATIENT'S STATUS HAD BEEN IMPROVING. ON (B)(6) 2007: PATIENT PRESENTED FOR NEUROLOGICAL FOLLOW UP. A RECENT X-RAY WAS REVIEWED WHICH SHOWED GOOD POSITION AND ALIGNMENT OF HIS INSTRUMENTATION. PATIENT COMPLAINED OF HAVING CHRONIC LOW BACK PAIN WHEN SITTING AND STANDING FOR LONG PERIODS OF TIME. ON (B)(6) 2009: PATIENT PRESENTED FOR REGULAR FOLLOW UP. ON (B)(6) 2010: PATIENT PRESENTED FOR REGULAR FOLLOW UP. PATIENT COMPLAINED OF THROAT PAIN, FEVER, HEADACHE, AND COUGH. ON (B)(6) 2010: PATIENT PRESENTED FOR REGULAR FOLLOW UP. ON (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINTS OF NECK PAIN, ON AND OFF BACK PAIN, IMPOTENCE, AND MUSCLE WEAKNESS. ON (B)(6) 2011: PATIENT UNDERWENT CT SCAN OF HEAD AND WAS DIAGNOSED WITH VERTIGO. IMPRESSION: NEGATIVE NON-CONTRAST CT SCAN OF THE BRAIN. ON (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED FOR REGULAR FOLLOW UP. PATIENT COMPLAINED OF NOT FEELING WELL, FATIGUE, HAD CHILLS, COUGH, PHLEGM (YELLOW) AND THROAT PAIN. ON (B)(6) 2014: PATIENT UNDERWENT MRI OF THORACIC SPINE, DUE TO BACK PAIN. IMPRESSION: DEGENERATIVE CHANGES WITH SMALL OSTEOPHYTES CAUSING MILD CENTRAL CANAL STENOSIS AND CORD IMPINGEMENT AT T2-3, T5-6, AND T7-8 LEVELS. FOCAL RIGHT PARACENTRAL DISC HERNIATION/ OSTEOPHYTE COMPRESSING THE RIGHT SIDE OF THE CORD AT T3-4 LEVEL. PATIENT ALSO UNDERWENT MRI OF LUMBAR PAIN SPINE. IMPRESSION: POST-OPERATIVE CHANGES WITH POSTERIOR FUSION FROM L4 TO S1 WITH SURGICAL PLATE AND PEDICLE SCREWS NOTED. DEGENERATIVE CHANGES OF THE ENDPLATES AND HYPERTROPHIC DEGENERATIVE CHANGES OF THE FACET JOINTS CAUSING MODERATE CENTRAL CANAL STENOSIS AT L3-4, MILD STENOSIS AT L4-5, L5-S1, AND L2-3 LEVELS. DEGENERATIVE DISC DISEASE AT THESE LEVELS MOST MARKED L4-5 AND L5-S1 LEVELS. NO EVIDENCE OF OSTEOMYELITIS OR DISC SPACE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163458 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115005AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other