BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3895572 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02915
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    March 8, 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)(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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE FROM L5 TO S1 USING RHBMP-2/ACS ON (B)(6) 2005. PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE LOW BACK PAIN, NUMBNESS IN HER LOWER EXTREMITIES, AND DIFFICULTY WALKING WITHOUT A CANE. IT WAS REPORTED THAT A LUMBAR CT PERFORMED ON (B)(6) 2014 REVEALED A NEUROCOMPRESSIVE LESION AT THE IMPLANT SITE. REPORTEDLY, THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING LOW BACK PAIN THAT RADIATES INTO HER LOWER EXTREMITIES. PATIENT HAS DIFFICULTY SLEEPING DUE TO PAIN, IS UNABLE TO SIT OR STAND FOR LONG PERIODS, AND MUST USE A CANE WHEN AMBULATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2000: PATIENT UNDERWENT MRI EXAMINATION OF THE LUMBAR SPINE. (B)(6) 2005: PATIENT UNDERWENT MRI EXAMINATION OF THE LEFT KNEE. IMPRESSION: INCREASED SIGNAL WITHIN THE POSTERIOR HORN AND BODY OF THE MEDIAL MENISCUS AS DESCRIBED, BEST DEMONSTRATED ON SAGITTAL IMAGING WHICH APPEARS TO EXTEND TO THE INFERIOR MENISCAL SURFACE. A VERY SMALL, DECOMPRESSED POPLITEAL CYST. A SMALL LEFT KNEE JOINT EFFUSION. ON (B)(6) 2005; (B)(6) 2006; (B)(6) 2007; (B)(6) 2013: PATIENT PRESENTED TO FOLLOW UP ON OSTEOARTHRITIS AND FIBROMYALGIA. PATIENT COMPLAINED OF LEFT HIP PAIN. IMPRESSION: PSORIASIS W/O OBVIOUS PSORIATIC ARTHRITIS. FIBROMYALGIA. MECHANICAL LOW BACK PAIN. OSTEOARTHRITIS. OSTEOPENIA. IRRITABLE BOWEL SYNDROME. GASTROESOPHAGEAL REFLUX. HYPERCHOLESTEROLEMIA. HYPERTENSION. STATUS POST LEFT KNEE ARTHROSCOPY FOR INTERNAL DERANGEMENT. LEFT HIP PAIN DUE TO TROCHANTERIC BURSITIS. STATUS POST LOW BACK SURGERY WITH PARESTHESIA LEFT LOWER EXTREMITY. PATIENT ALSO UNDERWENT X-RAY OF PELVIS, AP-INCLUDING BOTH HIPS. IMPRESSION: NEGATIVE PELVIS EXAM. ON (B)(6) 2005: PATIENT CALLED AND COMPLAINED OF CONTINUED LEFT HIP AND LEG PAIN. ON (B)(6) 2005: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK PAIN. ON (B)(6) 2005: PATIENT UNDERWENT RADIOGRAPHIC EXAMINATION OF THE LUMBAR SPINE. IMPRESSION: NO ACUTE FRACTURE OR SUBLUXATION WITH MILD SPONDYLOTIC CHANGES. PATIENT UNDERWENT MRI EXAMINATION OF THE LUMBAR SPINE. IMPRESSION: L5-S1: MILD DIFFUSE DISC BULGE WITH BILATERAL FACET HYPERTROPHY. FINDINGS RESULT IN RELATIVE SPINAL STENOSIS AND BILATERAL NEURAL FORAMINAL NARROWING. L3-4: MILD POSTERIOR DISC BULGE WITHOUT SIGNIFICANT STENOSIS. ON (B)(6) 2005: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK PAIN. ON (B)(6) 2005: PATIENT UNDERWENT CT OF LUMBAR SPINE, POST DISCOGRAM AND PHYSICAL EXAMINATIONS. IMPRESSION: HISTORY OF DISPLACED DISC AT L5-S1. POSSIBLE DISCOGENIC PAIN. ON (B)(6) 2005: PATIENT GOT ADMITTED AND WAS DIAGNOSED PRE-OPERATIVELY WITH CHRONIC LOW BACK PAIN AND LUMBAR DISK DEGENERATION WITH POSTERIOR DISKOGRAPHY AT L3-L4 AND L5-S1. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: MINIMALLY INVASIVE TRANSFORAMINAL DECOMPRESSION AND MICRODISKECTOMY AT L5-S1 ON THE LEFT. INTERBODY FUSION AT L5-S1 (BMP-II BONE GROWTH MATERIAL). PLACEMENT OF INTERBODY CAGE AT L5-S1. NON-SEGMENTAL FIXATION, L5-S1 ON THE LEFT. POSTEROLATERAL FUSION, L5-S1 ON THE LEFT (BMP-II PLUS LOCAL AUTOGRAFT). PER OP-NOTES: ¿¿ THEN WHILE WE FINISHED CLEANING OUT THE DISK SPACE, A KIT OF BMP-II WAS PREPARED SOAKED INTO COLLAGEN SPONGE¿ ONCE THE BMP-II WAS PREPARED FOR AN ADEQUATE TIME, THEN ABOUT TWO-THIRDS OF A 1 X 2 STRIP OF BMP-SOAKED COLLAGEN WAS PLACED INTO THE 8 MM CAGE AND THE CAGE WAS THEN DRIVEN INTO PLACE SECURELY AND SHOWED EXCELLENCE APPEARANCE ON FLUOROSCOPIC GUIDANCE. THEN AN ADDITIONAL 1 X 2 INCH STRIP WAS PLACED IN. I CUT IT IN HALF, PUT A PIECE OVER MEDIAL OR ON THE RIGHT SIDE OF THE CAGE AND A PIECE ON THE LEFT SIDE OF THE CAGE AND I HAD THIS SMALL THIRD OF A PIECE ON THE LEFT SIDE AS WELL.¿ ON (B)(6) 2005: PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: POSTERIOR FUSION OF L5 AND S1 INTACT WITHOUT EVIDENCE OF ABNORMALITY. ON (B)(6) 2006: PATIENT UNDERWENT X-RAYS OF LUMBOSACRAL. ON (B)(6) 2006: PATIENT UNDERWENT MRI EXAMINATION OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: LEFT POSTERIOR FUSION APPEARS TO BE INTACT WITH STABLE ALIGNMENT OF THIS REGION. MILD RETROLISTHESIS OF THIS REGION. NO EVIDENCE OF SPINAL STENOSIS AT ANY LEVEL. THE RIGHT NEURAL FORAMEN AT THE L5-S1 LEVEL IS NOT WELL SEEN, ALTHOUGH THERE MAY BE MILD RESIDUAL OR RECURRENT DISC BULGING, THERE IS MILD RIGHT SIDED NEURAL FORAMINAL ENCROACHMENT BUT WITHOUT CLEAR IMPINGEMENT. NO EVIDENCE OF ACUTE VERTEBRAL BODY HEIGHT LOSS ON (B)(6) 2006: PATIENT PRESENTED TO FOLLOW UP FROM HER MRI ON (B)(6) 2006. ON (B)(6) 2008: PATIENT UNDERWENT MRI EXAMINATION OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. COMPARISON STUDY WAS MADE WITH PREVIOUS MRI OF (B)(6) 2006. IMPRESSION: LEFT POSTERIOR FUSION AGAIN SEEN AT L5-S1 WITHOUT CENTRAL CANAL OR DEFINITE FORAMINAL ENCROACHMENT, ALTHOUGH THE LEFT FORAMEN IS NOT WELL IDENTIFIED. DISC DESICCATION WITH BROAD BASED POSTERIOR DISC BULGE WITH SLIGHT LEFT AND RIGHT LATERAL PROTRUSION AT L3-L4 RESULTING IN MILD THECAL SAC EFFACEMENT AND BILATERAL FORAMINAL ENCROACHMENT SLIGHTLY INCREASED FROM PRIOR STUDY. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY FOR BONE LENGTH STUDY. IMPRESSION: THE LEFT LEG IS 0.5 CM LONGER THAN THE RIGHT. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF LEFT FOOT. IMPRESSION: NO ACUTE BONY OR ARTICULAR ABNORMALITY IDENTIFIED. MILD SUBJECTIVE THICKENING OF THE DISTAL ACHILLES TENDON NEAR ITS CALCANEAL INSERTION. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF RIGHT FOOT. IMPRESSION: NO EVIDENCE OF FRACTURE. CALCIFICATION AT THE INSERTION OF THE ACHILLES TENDON ON THE RIGHT. OTHERWISE, NORMAL FOOT. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF RIGHT AND LEFT FOOT. IMPRESSION: DEGENERATIVE CHANGES AS NOTED INVOLVING THE GREAT TOE. NO FRACTURE OR BONE DESTRUCTIVE PROCESS. PATIENT ALSO UNDERWENT MRI OF LEFT JOINT, W/O CONTRAST. IMPRESSION: PARTIAL TEAR OF THE FLEXOR HALLUCIS LONGUS MUSCLE IN THE POSTERIOR ASPECT OF THE ANKLE JOINT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP OF RIGHT KNEE ARTHROSCOPY, WITH MEDIAL MENISECTOMY. SHE HAD MINIMAL DEGENERATIVE CHANGES TO THE MEDIAL COMPARTMENT. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF BILATERAL KNEES, RIGHT EQUAL TO LEFT. SHE HAD AN MRI SCAN OF THE RIGHT KNEE, WHICH SHOWED A QUESTIONABLE TEAR OF THE MEDIAL MENISCUS AND A LITTLE BIT OF DEGENERATIVE CHANGE TO THE MEDIAL COMPARTMENT THAT ARE FAIRLY MINIMAL. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LEFT FOOT PAIN, NUMBNESS AND TINGLING. MRI STUDY REVEALED MILD EDEMA AROUND POST-TIB TENDON, NO FX NOTED, SMALL GANGLION CYST NOTED IN SINUS TARSI. ON (B)(6) 2014: PATIENT UNDERWENT CT OF LUMBAR SPINE, W/O CONTRAST. THIS EXAM WAS COMPARED TO A STUDY FROM (B)(6) 2005. IMPRESSION: NO ACUTE FRACTURE-DISLOCATION IS SEEN. PST-SURGICAL CHANGE AS NOTED W/O CT EVIDENCE OF COMPLICATION. MILD MID LUMBAR SCOLIOSIS, CONVEX TO THE LEFT. MODERATE MULTILEVEL LUMBAR SPONDYLOSIS AS NOTED, MOST PRONOUNCED ON THE LEFT AT THE FUSION LEVEL OF L4-L5 SECONDARY TO BONY OSTEOPHYTOSIS, AND BILATERALLY AT L2-3 SECONDARY TO A BROAD-BASED DISC BULGE/OSTEOPHYTE COMPLEX. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF CHRONIC LUMBAR PAIN WITH LEFT EXTREMITY PAIN AND NUMBNESS AND TINGLING TO LOWER LEG ANTERIORLY. ON (B)(6) 2014: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK PAIN. PATIENT¿S ROS (REVIEW OF SYSTEMS) REVEALED: FATIGUE, INDIGESTION/HEARTBURN, JOINT PAIN, NUMBNESS/TINGLING, EXCESSIVE THIRST, SEASONAL ALLERGIES. ON (B)(6) 2014: PATIENT PRESENTED FOR FOLLOW UP FOR LOW BACK PAIN. ON (B)(6) 2014: PATIENT UNDERWENT MRI EXAMINATION OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: POSTOPERATIVE CHANGES FROM FUSION AT THE L5-S1 LEVEL. THE FUSION APPEARS SOLID ANTERIORLY. THERE IS SOME ENHANCING GRANULATION TISSUE IN THE LEFT EPIDURAL SPACE ADJACENT TO THE LEFT NEUROFORAMEN AT THIS LEVEL. DEGENERATIVE DISC DISEASE IS DEMONSTRATED AT THE L3-L4 AND L4-L5 LEVELS AS DETAILED IN THE BODY OF THE REPORT. THERE IS ASSOCIATED MILD BILATERAL NEUROFORAMINAL STENOSIS AT THE L3-L4 LEVEL. NO ABNORMAL ENHANCING MASS LESIONS ARE DEMONSTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370098 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M116002AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other