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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Arthritis (1723); Chest Pain (1776); Cyst(s) (1800); Edema (1820); Headache (1880); Neuropathy (1983); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Viral Infection (2248); Stenosis (2263); Discomfort (2330); Injury (2348); Post Operative Wound Infection (2446); Ambulation Difficulties (2544); Hematuria (2558)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent spine fusion surgery on the lumbar region at levels l5-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterior approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of chronic pain in her lower back and radiculopathy into her lower extremities, due to which patient underwent revision surgery.On (b)(6) 2010, the patient underwent spine fusion surgery on the lumbar region at levels l5-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.Patient still continues to experience constant and severe low back pain that radiates to her buttocks and lower extremities.Patient has swelling in her right leg, radiculopathy in both legs, and experiences difficulty walking.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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Additional information: (b)(4) - (persisting back pain, revision surgery, disc herniation).
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Event Description
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It was reported that on: (b)(6) 2007, the patient presented for a follow-up.Patient reported for back pain, down into both hips and down into the left leg to about her calf.She reported walking difficulty.Ct scan revealed spondylolisthesis and pars defect at the l5-s1 level.On (b)(6) 2007, the patient complained of pain in her back, pain down into her left leg.Mri revealed stenosis/foraminal stenosis at the l5-s1 level with a pars defect and spondylolisthesis.On (b)(6) 2007, the patient presented with admitting diagnosis: lumbar spondylolisthesis l5-s1.The patient underwent mri which revealed lumbar spondylolisthesis l5-s1 stenosis, lateral recess stenosis as well.Assessment: patient presented with severe back pain, pain unresponsive to conservative measures.The patient underwent x-ray.Impression: operative radiograph lumbar spine.On (b)(6) 2007, the patient presented with pre-op diagnosis: lumbar spondylolisthesis l5-s1, lumbar degenerative disc disease l5-s1.The patient underwent: l5-s1 decompressive laminectomy and removal of gill fragment, discectomy and posterior lumbar interbody fusion using interbody cage and pedicle screw stabilization l5-s1 using pedicle screw.As per op notes, distraction was carried across the disc space at the l5-s1.Plates were decorticated and then the interbody cage, size 10 mm was placed at the l5-s1 level.This was packed with bmp containing sponges and local allograft.Bmp containing sponges and local allograft were then placed in the posterolateral gutters.Patient tolerated the procedure well.On (b)(6) 2007, the patient underwent incision and drainage of wound due to post-op wound infection.On (b)(6) 2007, the patient underwent ct of lumbar spine w/o contrast.Impression: bilateral l5 pars defects confirmed.Some degree of neural foraminal stenosis at l5-s1.Degenerative disc disease at l1-2.On (b)(6) 2008, the patient underwent x-ray of left shoulder.Impression: slight widening of the ac joint, significance uncertain with some mild degenerative disc change.On (b)(6) 2008, the patient underwent x-ray of chest.Impression: placement of left picc line.Lungs clear.On (b)(6) 2008, the patient underwent x-ray of chest.Impression: picc line present.Clear lungs.On (b)(6) 2008, the patient ct of chest.Impression: diffuse fatty metamorphosis of the liver.Enlarged lymph node in the right axillsxxx with preservation of then fatty hilum.This may represent a reactive lymph node but correlation is requested.On (b)(6) 2008, the patient returned for follow-up due to tingling her in back along her incision/wound.On (b)(6) 2008, the patient underwent x-ray of lumbar spine.Impression: upper lumbar degenerative disc disease, most pronounced at the l1-2 level.On (b)(6) 2008, the patient returned for follow-up with some discomfort in her back around the area of her wound.On (b)(6) 2008, the patient presented with complains of intermittent back discomfort.X-rays reveal adequate progression.On (b)(6) 2010, the patient underwent x-ray of lumbar spine w/o contrast.Impression: degenerative disc disease at l1-4 with mild bulges and facet arthropathy.Post-op changes of anterior and posterior spinal fusion l5-s1 with laminectomy at l5 with findings consistent with incomplete healing.On (b)(6) 2008, the patient underwent x-ray of lumbar spine.Impression: interval development of sacral screw fracture, side unknown.On (b)(6) 2008, the patient came for a follow-up with discomfort in her back.The patient had increased lower back pain with some pain into her right thigh.Reported only intermittent discomfort.Review of x-rays of the lumbar spine revealed failure od the pedicle screw which appears to be on the left side.Fracture like through the neck of the pedicle screw.There appears to be bone growth bilaterally and in the posterolateral regions.On (b)(6) 2008, the patient underwent ct of lumbar spine.Impression: there was interval insertion of bilateral pedicular screws at l5 and s1.Patient had l5 laminectomy.The right screws at l5 and s1 traverse the anterior cortex.There was no loosening.There was material seen within the l5/s1 disc space, postsurgical.There was small ossific density seen in right paracentral location at l5/s1 which could be narrowing the lateral recess.The neural foramen appear at all visualized levels.The vertebral bodies are aligned.There is mild degenerative disc disease l1/2, unchanged.On (b)(6) 2008, the patient came for a follow-up.The ct scan revealed adequate progression of her fusion.The pedicle screw that broke appeared to be on the right side at s1.There was otherwise no loosening around the hardware.The patient had pain in her lower back.On (b)(6) 2009, the patient underwent mri of right and left knee w/o contrast.Impression: moderate to moderately advanced patellofemoral compartment degenerative arthritis with large areas of full thickness chondral loss and reactive marrow edema, subchondral cystic change and bony sclerosis.Possible small chondral body seen along the intercondylar notch.Focal chondral thinning posteromedial lateral tibial condyle with subchondral cystic change.Bone marrow edema involving the medial aspect of the lateral femoral condyle which is out od proportion to the adjacent chondral defects and may represent contusion.On (b)(6) 2009, the patient underwent x-ray of lumbar spine.Impression: status post laminectomy and surgical fusion at l5-s1 both s1 pedicle screws are fractured proximally.On (b)(6) 2009, the patient presented with lumbar pain.On (b)(6) 2009, the patient complained of low back pain and leg pain (thighs, calves and feet bilaterally).The patient noticed weakness of the thighs, calves and ankles bilaterally and the foot and big toe on the right.Ros: dizziness, seasonal allergies.Impression: posterior and anterior spinal fusion procedure from l4 through s1 with anterolisthesis of grade 1 l5 on s1 unchanged with flexion or extension.Degenerative disc disease at l1-2 and l5-s1.Calcification within the right upper quadrant that may represent bowel contents.On (b)(6) 2009, the patient underwent ct myelogram of lumbosacral spine.Diagnosis: evidence of degenerative disc disease at l1-2 and l2-3 with mild disc bulge at l2-3 but no central canal stenosis.There was a evidence of a posterior spinal fusion with the instrumentation and tlif at l5-s1 with a wide laminectomy of l5.Pseudoarthrosis present.Impression: degenerative disc disease at l1-l2 and l2-3 with mild disc bulge at l2-3.Post-op changes of anterior and posterior changes spinal fusion l5-s1.On (b)(6) 2010, the patient presented for a post-op visit.The patient developed wound infection and subsequently a pseudoarthrosis.She had low back pain and leg pain.On (b)(6) 2010, the patient presented with following admitting diagnosis: disease and disorder of the musculoskeletal system and connective tissue, mechanical complication of other internal orthopedic device implant and graft.Secondary diagnosis: post-laminectomy syndrome, cervical region.Unspecified acquired hypothyroidism.Depressive disorder, chronic pain.The patient presented with pre-op diagnosis: lumbosacral spine disease.The patient underwent left retroperitoneal exposure of l5-s1 disk space.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on :(b)(6) 2007 the patient was admitted to the hospital.Diagnosis on admission: lumar spondylolisthesis l5-s1.As well as medical history of hypothyroidism, osteoarthritis, bronchitis, sinusitis, gastroesophageal reflux disease, depression.The patient underwent l5-s1 laminectomy.On (b)(6) 2008 the patient underwent x-ray of left shoulder.Impression: slight widening of the ac joint, significance uncertain with some mild degenerative disc change.The patient also underwent x rays of the chest.Impression: new streaky sub-segmental atelectasis overlies the right hilum on the current examination.Post surgical changes at the lower cervical spine.On (b)(6) 2008 the patient was presented for office visit with fever.Impression: postoperative fever.Hypothyroidism, depression and gerd.The patient underwent x rays of the chest.Impression: persistent somewhat small lung volumes although there is slight improved level of inspiration.Persistent mild elevation of the right hemidiaphragm and streaky right atelectasis.The patient underwent ct scan of the lumbar spine.Impression: grossly expected findings post laminectomy and posterior fusion at l5-s1 including evidence of interbody fusion.Prominent non specific posterior extraspinal grossly midline soft tissue density changes in the operative area.No definite abnormal fluid collection or abscess or mass is defined in this non contrast scan.On (b)(6) 2008 the patient was presented for office visit with surgical site infection.Impression: surgical site infection with lumbar wound taken to the operating room with superficial and deep drainage.The patient is status post l5-s1 decompression laminectomy with removal of gill fragment, discectomy, and posterior lumbar interbody fusion using the interbody cage and pedicle screw stabilization.On (b)(6) 2008 the patient underwent ct scan of the abdomen.Impression: postoperative changes of the lumbar spine.No evidence of intra-abdominal abscess of fluid collection.Simple cyst of the left kidney.On (b)(6) 2008 the patient underwent mri of the lumbar spine.Impression: increased epidural signal on the fat-saturated post-contrast images.These findings are concerning for an infectious process in the epidural space.This finding is most prominent at the l5-s1 levels, however the abnormal epidural enhancement does extends superiorly.Enhancement along the endplate of the l5-s1 levels.Fusion device has been inserted at the l5-s1 level anteriorly, and these findings may all be postsurgical in nature.Posterior spinal instrumentation.On (b)(6) 2008: the patient returned for follow-up with some discomfort in her back around the area of her wound.On (b)(6) 2008: the patient presented for follow up on stress.On (b)(6) 2008: the patient presented for follow up on "b/w" and hurting ears.On (b)(6) 2008: the patient presented with hurting throat, drainage, head congestion.On (b)(6) 2009: the patient presented with sinus infections.On (b)(6) 2009: the patient presented with hurting stomach and lower back pain.On (b)(6) 2009: the patient presented with a sinus infection with a productive cough and greenish sputum.On (b)(6) 2009 the patient underwent x-ray of lumbar spine.Impression: status post laminectomy and surgical fusion at l5-s1 both s1 pedicle screws are fractured proximally.On (b)(6) 2009: the patient presented with cough, runny nose, congestion.On (b)(6) 2009: the patient presented with a complaint of sinus infection and hurting nose.On (b)(6) 2010: the patient presented with a chief complaint of thick mucous, lower right back pain and a thought of sinus infection.On (b)(6) 2010: the patient presented for follow up for kidney function and cough.On (b)(6) 2010: the patient presented with hurting back and cough.On (b)(6) 2010: the patient underwent renal ultrasound due to hematuria and right flank pain.Impression: no obvious renal abnormality.Limited exam due to bowel gas.On (b)(6) 2010: the patient presented with a cough with dark green sputum and headache.On (b)(6) 2010: the patient underwent ct of the sinuses without contrast due to chronic sinusitis.Impression: mild chronic sinus inflammatory changes.On (b)(6) 2010: the patient presented for follow up on cough.
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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On (b)(6) 2010 the patient was presented for office visit with bilateral knee pain.She reported that she had ambulation difficulty, burning sensation in the anteromedial aspect of her knees.Impressions: low back pain with potential hardware complications, bilateral knee pain and arthritis predominantly in the patellofemoral compartments.The patient also underwent x rays of the bilateral knee.This showed evidence of patellofemoral compartment, predominant osteoarthritis of the bilateral knees, greater on the right side.In addition, the right medial knee compartment has some joint space narrowing, more then the left medial compartment as well.On (b)(6) 2010: the patient presented with a chief complaint of thick mucous, lower right back pain and a thought of sinus infection.Impression: urine tract infection , acute sinusitis, lumbago , chest pain , tinnitus.On (b)(6) 2010 the patient was presented for office visit.Impression: pseudoarthrosis at l5-s1 following a posterior spinal fusion with instrumentation and tlif at l5-s1 performed (b)(6) 2007 and complicated by the development of the post operative wound infection requiring irrigation and debridement and vac dressing placement.The patient also underwent ct scan of the lumbar spine.Impression: degenerative disc disease at l1-4 with mild disc bulges and facet arthropathy as described above; postoperative change of anterior and posterior spinal fusion l5-s1 with laminectomy at l5 with findings consistent with incomplete healing.The patient underwent mri for lumbar spine.Impression: multilevel degenerative changes of the lumbar spine as described in detail above; status post anterior and posterior spinal fusion of l5-s1.
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