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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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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Apnea (1720); Arthritis (1723); Calcium Deposits/Calcification (1758); Congenital Defect/Deformity (1782); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Gastritis (1874); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Burning Sensation (2146); Tingling (2171); Hernia (2240); Stenosis (2263); Injury (2348); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Dysuria (2684)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(6) 2009, patient underwent spinal fusion surgery on the lumbar region of her spine from vertebrae t4 to t12 and l4 to s1.Reportedly, during the surgery, rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Posterior approach was used for this surgery.On (b)(6) 2009, the surgeon performed spine fusion surgery on the lumbar region of the patient's spine from vertebrae l5 to s1 using rhbmp-2 collagen sponge.Allegedly, post-operative period had been marked by left leg pain and swelling; extreme burning in her low back, left hip and left leg; and chronic low back pain with radiation to both hips and legs, and into the left ankle.The patient is unable to work, has limited mobility, and is unable to sit, stand or drive for extended periods.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she has otherwise suffered serious and permanent injuries.
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Manufacturer Narrative
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Additional information: pt and device info.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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It was reported that on : (b)(6) 2009 the patient underwent x rays of the abdominal.Spinal fixation hardware in the lumbar spine extending into the iliac bones bilaterally seen.Several clips are noted within the pelvis.On (b)(6) 2009 the patient was discharged from the hospital.Principal diagnostic test: lumbosacral spondylosis without myelopathy.Secondary test: kyphosis, infection and inflammatory reaction due to other vascular device/implant/graft.Unspecified hyperlipidemia.Obstructive sleep apnea.Surgical operation, anastomosis/bypass/graft, with abnormal reaction/later, no surgical misadventure.Injury or poisoning occurring at/in residential institution.Procedure: lumbar/lumbosacral fusion, anterior technique.Excision of intervertebral disc.Intra-abdominal vascular shunt/bypass.Fusion or refusion of 2-3 vertebrae.Insertion of interbody spinal fusion device.Insertion pf recombinant bone morphogenic protein.Venous catheterization.Transfusion of packed cells.On (b)(6) 2009 the patient underwent anterior lumbar discectomy at l5-s1.Anterior lumbar interbody fusion at l5-s1.Placement of intervertebral device at l5-s1 utilizing the depuy cougar carbon reinforced peek cage system.Augmentation of anterior spinal fusion with rhbmp-2 (12mg on acs at 1.5mg/ml graft volume concentration).Preoperative diagnosis: lumbar spondylosis with transition syndrome at l5-s1.Lumbar kyphosis, status post anterior/posterior spinal fusion from t12 to l5, performed in 1986.Status post removal of implants from t12 to l5, performed in 1988.Status post revision posterior spinal fusion with instrumentation from t4 to s1 / ilium, performed on (b)(6) 2009.Per-op notes: ¿in fact, the bicortical s1 screw placed at the time of the patient¿s last surgery on (b)(6) 2009, was noted to abut the common iliac vein.Once this was done, attention was then turned towards performing an interbody fusion at the l5-s1 level.In order to achieve a fusion and provide anterior column support, we used the depuy cougar carbon reinforced peek cage system.The cage was packed with 12mg of rhbmp-2 on acs at 1.5mg/ml graft volume concentration was then impacted in place.We then placed 2.5 ml of dynagraft over the cage to seal in the bmp.¿ on (b)(6) 2009 the patient underwent left retroperitoneal approach to the spine on the l5-s1 interspace.Partial resection of the left common iliac vein with cryopreserved vein interposition bypass.Preoperative diagnosis: lumbosacral spinal disease.Patient underwent intra-op radiograph of spine.On (b)(6) 2009, patient underwent x-ray of chest.On (b)(6) 2009 the patient underwent x rays of the chest due to shortness of breath.Impression: subsegmental atelectasis is present in both lung bases.The lungs are under infiltrated and otherwise grossly clear.The patient also underwent x rays of the t-l spine.Impression: posterior spinal fusion, t4 to s1 and the bilateral iliac.Anterior spinal fusion, l5-s1.On (b)(6) 2009 the patient was presented for office visit with numbness to left inner thigh.Impression vein graft infection.On (b)(6) 2009, patient presented for office visit for clinical and radiographic evaluation following an anterior lumbar interbody fusion at l5-s1 performed on (b)(6) 2009, and a posterior spinal fusion with instrumentation from t4 to s1 / ilium performed on (b)(6) 2009.Patient underwent x-ray of thoracolumbar spine scoliosis standing.Impression: post surgical changes of instrumented posterior spinal fusion procedure from t4-s1 with 19 degrees of residual levoscoliosis of the lumbar spine; anterior spinal fusion procedure at l5-s1.On (b)(6) 2009, patient underwent radiographic study of upper gi with air contrast due to dysphagia.Impression: moderate partially reducible hiatal hernia and mild gerd associated with mild erosive esophagitis and low grade stenosis.Normal views of the stomach and duodenum.On (b)(6) 2009, patient presented for office visit for clinical and radiographic evaluation following an anterior lumbar interbody fusion at l5-s1 performed on (b)(6) 2009, and a posterior spinal fusion with instrumentation from t4 to s1 / ilium performed on (b)(6) 2009.Patient underwent x-ray of thoracolumbar spine scoliosis standing.Impression: unchanged instrumented posterior spinal fusion procedure from t4 to the sacrum and bilateral iliac wings and instrumented anterior spinal fusion procedure and discectomy at l5-s1 with unchanged levoscoliosis and kyphosis of the lumbar spine.On (b)(6) 2010, patient underwent x-ray of cervical spine.Impression: no anomalous features of cervical spine.Advanced degenerative disc disease at the c5-6 level associated with mild spinal stenosis.No evidence of spinal instability under stress.Patient underwent x-ray of thoracolumbar spine.Impression: extensive orthopaedic stabilization of the thoracolumbar spine related to congenital deformity of the lumbar spine.On (b)(6) 2010, patient underwent esophagogastroduodenoscopy due to dysphagia and gerd.Impression: hiatal hernia, evidence of gastric reflux, otherwise unremarkable upper endoscopy.On (b)(6) 2010, patient underwent mri of cervical spine with and without gandolinium enhancement.Impression: multilevel degenerative spondylosis is dominant at c5-6 and c6-7 associated with severe impingement of the left c6 nerve root and moderate impingement of the right c6 and left c7 nerve roots as well as the ventral cord.On (b)(6) 2010, patient underwent bilateral mammogram.Impression: moderately dense bilateral stromal pattern, which reduces sensitivity of mammography.Multiple bilateral benign appearing smooth microcalcifications again noted with probable mild increase in number of these calcifications on the left.On (b)(6) 2010, patient presented for office visit for repeat clinical and radiographic evaluation following a posterior spinal fusion with instrumentation from t4 to s1/ilium performed on (b)(6) 2009 and alif at l5-s1 performed on (b)(6) 2009.Patient reported that she had developed pain in her upper back with radiation to the shoulder blade area.She has also had some persistent low back pain.As a result she has found it impossible to return to work.Plain radiographs obtained at the time of today¿s office visit were reviewed.These demonstrate evidence of a posterior spinal fusion with instrumentation from t4-s1/ilium and alif at l5-s1.All implants appear to be in good position and there is no evidence of implant loosening of implant failure.I think that there is a solid fusion present.Impression: satisfactory follow-up status post posterior spinal fusion with instrumentation from t4-s1/ilium performed on (b)(6) 2009 and alif at l5-s1 performed on (b)(6) 2009.Persistent thoracic pain and low back pain.On (b)(6) 2010, patient underwent x-ray of thoracolumbar scoliosis spine.Impression: unchanged t4 through bilateral iliac wing instrumented posterior spinal fusion with fractured l5 pedicular screw; unchanged l5-s1 anterior discectomy and fusion, unchanged lumbar levoscoliosis and thoracolumbar kyphosis; l1 gibbous deformity.On (b)(6) 2014, patient underwent x-ray of lumbar spine.Impression: orthopedic stabilization of severe lumbar kyphosis related to anomalous segment.No acute or localizing osseous abnormality identified.On (b)(6) 2014, patient presented for office visit due to lump over left side of abdomen which rises and falls hen she changes position.Patient also reported low back pain which radiates down both hips into anterior legs and ankle area.On (b)(6) 2014, patient underwent procedure: open incisional hernia repair with mesh, possible laparoscopy and laparoscopic assisted incisional hernia repair; admitting diagnosis: incisional hernia.No complications were reported.On (b)(6) 2014, patient underwent nuclear whole body scan including spect imaging.Indications: chronic low back pain, congenital scoliosis, stabilization surgery in 2008.Impression: focal increased activity is seen in the region of the thoracolumbar junction or l1 region especially on the left side.Increased activity near lumbosacral junction and the finding suggest degenerative changes or stress reaction.On (b)(6) 2013, (b)(6) 2014, patient presented for follow-up on chronic low back pain.On (b)(6) 2014, patient underwent esophagogastroduodenoscopy (egd) and colonoscopy for pre-op diagnosis of: abdominal pain, bloating, nausea and gerd; and post-op diagnosis of: gastritis, hiatal hernia.Findings: the duodenum was normal, no ulcers, lesion or masses were noted.Stomach showed gastritis.Biopsies were taken.A j turn maneuver revealed a normal fundus.Esophagus revealed a small hiatal hernia.On (b)(6) 2014, patient underwent bilateral mammogram.Impression: no suspicious findings.On (b)(6) 2014, patient presented for follow-up visit.On (b)(6) 2014, patient presented for office visit due to back pain and swelling of left leg.Swelling gets worse as the day progresses.On (b)(6) 2014, patient presented in er due to acute neck pain and right shoulder pain.Patient was administered im pain medication with little relief.On (b)(6) 2014, patient underwent ct scan of cervical spine without contrast due to neck pain radiating to the right shoulder.Impression: advanced degenerative disc disease largely confined to the c5-6 level with predominantly left sided hypertrophic changes creating severe left c6 foraminal stenosis and likely chronic neural impingement.On (b)(6) 2014, patient presented for follow-up visit on neck pain.Patient underwent ct of cervical spine.Impression: severe degenerative disease at c5-6 level with spur formation.
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Event Description
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It was reported that on, (b)(6) 2010: patient underwent mri of cervical spine with and without contrast.On (b)(6) 2014: the patient presented with a complaint of hernia, lower stomach pain and increased cholesterol.On (b)(6) 2014, patient underwent procedure: open incisional hernia repair with mesh, possible laparoscopy and laparoscopic assisted incisional hernia repair; admitting diagnosis: incisional hernia.No complications were reported.The patient also underwent ct of abdomen pelvis due to history of left lower quadrant hernia pre-op.Impression: no evidence of ventral wall or inguinal hernia seen.Post operative change of the spine with deformity noted.On (b)(6) 2014: patient underwent "nm bone/or jt whole body" radiological test.On (b)(6) 2014:patient presented for office visit.On (b)(6) 2015, the patient presented with pain in thoracic spine.Impression: acute on chronic back pain.On (b)(6) 2015 patient underwent radiology on nuclear medicine body bone scan including detail views of the thoracic spine.Impression: mild focal uptake thoracic spine posterior elements suggesting stress reaction probably related to orthopedic hardware.On (b)(6) 2015, the patient presented for cough and neck pain.On (b)(6) 2015, the patient presented with back pain.On (b)(6) 2016, the patient presented for pathology examination.The patient had sore on foot and back pain.The patient had infection in the left foot.On (b)(6) 2016, the patient presented for utl, left groin pain, abdominal pain, dysuria.On (b)(6) 2016, the patient presented for arthritic pain in her lower back and legs.Patient also states her muscle felt sore.Her system review showed numbness in extremity and swelling, back pain , joint pain , muscle soreness.The patient had knee x-ray review.Impression: mild osteoporosis.Patient also complained of backache.On (b)(6) 2016, the patient presented for neuritis, left knee pain , low back pain , pain in left hip.The patient underwent physical therapy.
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Manufacturer Narrative
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(b)(4) (leg pain).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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It was reported that on, (b)(6) 2009: findings: there has been interval insertion of a left peripherally inserted central catheter overlying the upper right atrium, the tip obscured from view due to the overlying spinal instrumentation which extends from the mid-thoracic to the upper lumbar spine.Small lung volumes are present with mild right basilar atelectasis.On (b)(6) 2009: patient underwent polysomnography and was found to have sleep apnea and diagnosed with obstructive sleep apnea.On (b)(6) 2010, patient presented for office visit.Patient reported back pain which radiates to shoulders, left knee and hip pain.On (b)(6) 2011: patient presented for an internist examination.Impression: kyphosis; patient had moderate scoliosis in her upper back.Gait was significant for a minimal-to-mild limp.On (b)(6) 2011: patient presented with chronic neck, back and head pain.Review of systems: musculoskeletal: arthritis, neck pain, joint pain; neurologic: headaches.Assessment: chronic neck and low back pain.On (b)(6) 2012: patient presented for follow up visit.Review of systems: neurologic: headaches, numbness/tingling.Musculoskeletal: arthritis, neck ,back and joint pain.On (b)(6) 2012: patient presented for office visit.Assessment: chronic neck and low back pain.On (b)(6) 2012: patient presented with complains of lower back, leg numbness getting worse and left leg pain.On (b)(6) 2012: patient presented with chief complaint of neck and right shoulder pain.On (b)(6) 2012: patient was hospitalized due to back and leg pain.On (b)(6) 2012: findings: no visible fracture or dislocation.No advanced arthrosis, post surgical changes noted in the pelvis with fusion bar in the ileum and clips in the left hemi pelvis.On (b)(6) 2012: patient presented for follow up visit for left hip and left knee pain.Review of systems: musculoskeletal: hip and knee joint pain.On (b)(6) 2013: patient presented with neck pain.On (b)(6) 2013: patient was diagnosed with chronic low back pain, foraminal stenosis, bilateral hip and leg radiculopathy and presented for pain management.On (b)(6) 2013: patient was diagnosed with degenerative disc disease, foraminal stenosis with bilateral radiculopathy.
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Manufacturer Narrative
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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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It was reported that on (b)(6) 2014: patient presented for office visit.The patient underwent x-ray of thoracic spine due to history of mid back pain.Impression: extensive post-surgical changes of the thoracic spine without definite acute osseous abnormality.The patient underwent x-ray of cervical spine due to history of neck pain.Impression: mild cervical spondylosis favoring c5-c6.(b)(6) 2014: the patient underwent mri of cervical spine without contrast due to severe neck pain.The results were compared with those of the cervical spine radiograph obtained on (b)(6) 2014.Impression: mild to moderate cervical spondylosis greatest from c3-4 through c6-7.
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