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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
Pulmonary Embolism (1498); Syncope (1610); Chest Pain (1776); Edema (1820); High Blood Pressure/ Hypertension (1908); Pain (1994); Pleural Effusion (2010); Loss of Range of Motion (2032); Renal Failure (2041); Scarring (2061); Swelling (2091); Urinary Retention (2119); Stenosis (2263); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a spine fusion surgery at t9-l5 using rhbmp-2/acs.Patient's post-operative period was marked by increasingly severe pain in his low back and lower extremities.Patient self-catheterizes to urinate, he consults regularly with a nephrologist to maintain kidney function.Patient had a spinal pain pump implanted and surgically revised twice, he is now seeking to have it removed.Patient consults regularly with a urologist to treat sexual dysfunction that developed following his rhbmp-2/collagen sponge exposure.Patient continues to experience severe and unrelenting pain in his low back, and hips, and radiating pain and numbness in his lower extremities.He is unable to ambulate without a cane or walker.Patient developed severe neurogenic bladder, requires a urinary catheter, and he is unable to perform sexually.
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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.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) 2008, the patient presented with the following preoperative diagnoses: thoracic myelopathy secondary to thoracic herniated nucleus pulposus with bilateral lower extremity weakness and bowel and bladder changes.Fixed sagittal imbalance status post posterior spinal fusion l1-l5.Chronic lumbar back pain.The following procedures were performed: fusion mass exploration l1-s1.Instrumentation removal bilateral l1, l2, l3, l4, l5, s1.Revision bilateral posterior segmental spinal instrumentation l1-s1.T10-t11 smith ¿ peterson osteotomy.T10 ¿t11 discectomy (total).T10 ¿t11 anterior spinal fusion augmented with local bone graft and bone morphogenic protein-2.L1-l2 and l2-l3 smith peterson osteotomies of former fusion mass.Complex extra cavitary corpectomy l3.Posterior spinal fusion t9-t10, t10-t11, t11-t12, t12-l1 and revision posterior spinal fusion l1-s1.Augmentation of posterior spinal fusion t9 ¿ l5 with recombinant human bone morphogenic protein -2, ceramic bone graft extender compressive resistant matrix and local bone graft.Per op notes: ¿they decorticated the posterior elements very carefully from t9-l5, and then placed 30 mg of bone morphogenic protein with compressive resistant matrix especially across the t10 ¿ l3 in rolls.¿ remaining local bone graft as well as the bone morphogenic protein and 1g of vancomycin powder were placed over the remaining dorsal elements.¿ on (b)(6) 2008, the patient presented had single view abdomen examination.On (b)(6) 2008, the patient presented with complaint of severe back <(>&<)> leg pain.The patient underwent mri of lumbar spine.Impression: minor compression deformities are suspected.2) there was no significant central spinal canal stenosis.On (b)(6) 2008, the patients presented with complain of mid thoracic back pain.On (b)(6) 2008, the patient called to complain of major mid <(>&<)> upper back pain.On (b)(6) 2008, the patient presented with complaint of bilateral mid lumbar back pain.Impression: negative for chest pain, pulmonary issues or cardiovascular issues.His gastrointestinal symptoms are also negative.On (b)(6) 2008, (b)(6) 2007, the patient presented for follow up.Impression: postoperative pe.Urinary retention.Chronic back pain.Htn.Copd/ tobacco abuse.Generalized anxiety.Alcohol dependence.Insomnia.On (b)(6) 2009, the patient presented with complaint of back pain.The patient underwent trigger point injection procedure.On (b)(6) 2009, the patient presented for physical therapy.On (b)(6) 2009, the patient called and complaint of swelling middle back.On (b)(6) 2009, the patient presented with thoracic back pain, radiating pain, numbness right foot.On (b)(6) 2009, the patient presented with complaint of mid- low back pain, bilateral lower extremity pain and right lower extremity numbness.Musculoskeletal study review: complained of back pain, neck pain; neurologic study review: complained of numbness, paresthesias.On (b)(6) 2009, the patient presented with complaint of low back and bilateral lower extremity pain.On (b)(6) 2009, the patient presented with complaint of low back pain and bilateral lower extremity pain, neck pain and upper extremity pain.The patient underwent nerve conduction studies, reflex studies, wave studies etc.On (b)(6) 2009, the patient presented for office visit for data review and supervisory.Impression: post laminectomy syndrome lumbar spine with persistent low back pain conservative measures thus far.On (b)(6) 2009, the patient presented for follow up from his surgery.X-rays show a t9 through the sacrum posterior spinal fusion with increased bone formation posteriorly compared to previous x-rays.On (b)(6) 2009, the patient presented for a follow up visit.Impression: chronic neck/ back pain.Mixed mood symptoms / stressors.Chronic insomnia, multifactorial.Urinary retention.Copd.Microcytic anemia.Elevated creatinine.History of alcohol dependence.History of pneumonia.On (b)(6) 2010, the patient called in with complaints of burning and hurting after he cathed himself.The patient underwent ct scan of the abdomen.Conclusion: uniform wall thickening of the urinary bladder.This apparently causes partial obstruction of each ureterovesical junction resulting in moderate bilateral pyelocaliectasis with ureterectasis.No renal or ureteral calculi were identified.On (b)(6) 2010, the patient underwent x-ray of the chest.Impression: no cardiomegaly, pneumonia or interstitial edema.Blunting of the right costophrenic angle, probably due to pleural scarring.On (b)(6) 2010, the patient was admitted with the following complaints: postobstructive diuresis and elevated creatinine.A comparison of chest radiograph was done.Impression: mild blunting of the right lateral costophrenic angle which may represent scarring versus a small pleural effusion.Postoperative and degenerative changes of the spine.No focal consolidation.On (b)(6) 2010, the patient was transferred to southeast missouri hospital in post obstructive diuresis.On (b)(6) 2010, the patient was admitted with the following diagnoses: post obstructive urinary retention.Elevated post void residual.Elevated serum creatinine.History of gross hematuria.The patient underwent the following procedures: cystoscopy.Bilateral retrograde pyelograms.Bladder biopsies times two.Fulguration of bleeding at biopsy sites.Foley catheter placement.On (b)(6) 2010, the patient underwent a cystoscopy , bilateral retrograde pyelograms and bladder biopsy.On (b)(6) 2010, the patient underwent urodynamic studies.There was no evidence of any detrusor sphincter dyssynergia.On (b)(6) 2011, the patient underwent x-ray of the pelvis.Conclusion: no fracture or cortical erosion.Post-operative changes were noted at l4 and l5.On (b)(6) 2011, (b)(6) 2010, the patient presented for follow up.On (b)(6) 2012, the patient presented for follow up on complaints of chronic medical problems.Ros: musculoskeletal: positive for back, neck and left shoulder pain.On (b)(6) 2012, the patient presented with chief complaint of ankle swelling.On (b)(6) 2012, the patient presented for follow up.Ros: musculoskeletal: positive for back pain, neck pain and left shoulder pain.Psychiatric: positive for anxiety, depression, feelings of stress and insomnia.On (b)(6) 2014, the patient presented for an office visit and underwent physical examination.Impression: cervical and lumbar spondylosis with multiple surgeries.Failed back syndrome.Left shoulder pain with four previous surgeries.Opioid dependence and hypotestosteronism probably secondary to chronic opioid use.On (b)(6) 2014, the patient presented for follow with complaints of pain in back and leg.On (b)(6) 2014, the patient presented for his annual exam due to pain in his back.On (b)(6) 2014, the patient presented for an office visit and underwent physical examination.Impression: cervical and lumbar spondylosis with multiple surgeries.Failed back syndrome.Left shoulder pain with four previous surgeries.Opioid dependence.Hypotestosteronism.History of recent pneumonia.Right lung tumor at this time not defined as to what it is, either benign or malignant.
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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) 2009: patient arterial doppler examination.Impression: the ankle-brachial index was 1.19 measured at the posterior tibial artery and 1.14 measured at the dorsalis pedis artery.Impression: the ankle-brachial indices were within the normal range.On (b)(6) 2009: patient underwent myocardial perfusion due to chest pain.Impression: normal myocardial perfusion imaging.Normal left ventricular ejection fraction and normal wall motion.On (b)(6) 2010: patient underwent x-ray of chest.Impression: emphysematous change with hyperexpansion.No acute pneumonic consolidation.Residual right pleural parenchymal scarring verse tiny pleural effusion.On (b)(6) 2010, the patient underwent a cystoscopy, bilateral retrograde pyelograms and bladder biopsy.Findings: film shows multiple intrapedicular screws throughout the lumbar spine extending from at least t1 through approximately s1 with interconnecting rods.There appears to be disc prostheses at l4-l5 and l5-s1.On (b)(6) 2010: as per telephonic records, patient had a lot of pain in left groin area.On (b)(6) 2011: the patient presented for follow up of history of neurogenic bladder.On (b)(6) 2011, (b)(6) 2010, the patient presented for follow up for history of urine retention and underwent bilateral lower extremity doppler venous ultrasound.Conclusion: no dvt in either lower extremity.On (b)(6) 2011: patient underwent x-ray of chest.Impression: mild right basilar fibrosis.No pneumothorax, acute focal consolidation or pulmonary edema.On (b)(6) 2011: patient underwent x-ray of cervical spine.Impression: post-surgical changes of a c4 through c7 anterior fusion.No hardware failure, acute fracture, or subluxation.On (b)(6) 2011, (b)(6) 2012: the patient presented with right ankle pain.On (b)(6) 2011: patient underwent ct of thoracic spine without contrast.Impression: there was a normal appearance of the fusion hardware.No fracture were seen within the thoracic spine.On (b)(6) 2012: patient underwent x-ray of chest.Impression: postsurgical changes in the cervical and thoracolumbar spine.Granulomatous changes.No active cardiopulmonary disease.On (b)(6) 2012: the patient underwent mri of left shoulder.Conclusion: no marrow edema-contusion.No glenoid labral tear.Mild bony overgrowth of the left ac joint but this does not cause any significant impingement.Fluid in the subcranial and subdeltoid bursa, most compatible with bursitis.On (b)(6) 2012, (b)(6) 2013: the patient presented with left shoulder rotator cuff arthropathy.On (b)(6) 2012, (b)(6) 2013: the patient presented for follow up for pain in lower back.On (b)(6) 2012: the patient underwent ultrasound of left shoulder.Impression: large articular sided water shed area tear of the supraspinatus.Distal articular sided subscapularis tear.On (b)(6) 2012: the patient underwent mri of cervical spine due to cervical pain.Conclusion: c3-c4: mild narrowing of the right neuroforamen due to right uncinated joint degenerative changes.C4-c5: the spinal canal was at the lower limits of normal in size, probably due to congenital short pedicles.C5-c6: the spinal canal was at the lower limits of normal in size, probably due to congenital short pedicles.No disc bulge or herniation was noted.On (b)(6) 2012: patient underwent x-ray of chest due to syncope and back pain and chest pain.Impression: no acute cardiopulmonary disease.Patient also underwent ct of brain without contrast.Impression: ct of the brain within normal limits.Patient also underwent ct of cervical spine without contrast.Impression: multilevel cervical fusion.No acute abnormalities.On (b)(6) 2012: patient underwent bilateral lower extremity venous doppler test.Impression: negative bilateral lower extremity venous doppler.Patient also underwent x-ray of orbits for foreign body.Impression: no metallic foreign body overlying the orbits.Patient also underwent perfusion lung scan.Impression: normal lung perfusion study.On (b)(6) 2012: patient underwent x-ray of cervical spine.Impression: postsurgical changes of a c4-c7 fusion.No hardware failure or acute fracture.No segmental instability with flexion and extension positioning.Patient also underwent ct of cervical spine.Impression: there is no evidence of acute fracture or dislocation there is evidence of narrowing of the central canal at the c4-5, c5-6 and c6-7.There is evidence of multilevel foraminal narrowing including mild narrowing at c3-4, mild right and mild to moderate left stenosis c4-5, mild to moderate bilateral stenosis at c5-6, and mild to moderate bilateral stenosis at c6-7.Patient also underwent ct of thoracic spine.Impression: the current ct examination demonstrates the thoracic vertebrae and intervertebral disc to be stable in appearance when compared to patient's earlier examination.There was no evidence of new fracture or dislocation.There was evidence of multilevel degenerative disc disease and spondylosis and of mild chronic wedge type compression deformity t7.Interval introduction of neurostimulator electrodes at the t8-9 level of the ascending to the level of t4.Examination demonstrated narrowing of the neural foramina at level several levels primarily from t8-9 through t11-t12.On (b)(6) 2012: the patient presented with mri of left shoulder.Conclusion: residual marrow edema from the patient's surgery in (b)(6) 2012 involving the left humeral head and left proximal humeral metaphysis.No glenoid labral tear.The biceps tendon is very thin-attenuated.It is not displaced from the bicipital tendon groove.Mild bony and fibrous overgrowth of the left ac joint was noted which does cause mild impingement.Large partial thickness tear involving the left supraspinatus tendon, resulting in leakage of dilute gadovist into the subacromial, subdeltoid bursa and the left ac joint.On (b)(6) 2013: the patient presented with pain in right foot and left shoulder.On (b)(6) 2013, (b)(6) 2014: the patient presented for medications.On (b)(6) 2013, (b)(6) 2014: the patient presented with left shoulder pain.On (b)(6) 2014: patient underwent x-ray of chest due to chest pain.Impression: right lower lobe pneumonia.On (b)(6) 2014: patient underwent x-ray of chest post bronchoscopy.Impression: no pneumothorax.Atelectasis and/or pneumonia in the lower lungs bilaterally, greater on the right.On (b)(6) 2014: patient underwent ct-guided biopsy mass within the superior segment of the right lower lobe.Impression: successful ct-guided biopsy of the right lower lobe.Patient underwent x-ray of chest.Impression: no pneumothorax following biopsy.On (b)(6) 2014: on a telephonic conversation patient stated pain due to lung issues.On (b)(6) 2014: patient underwent x-ray of chest due to right sided chest pain.Impression: stable posterior right lung mass with adjacent and/or pneumonia in the posterior right mid lung and to lesser extent, the right lung base.On (b)(6) 2014: patient underwent ct of chest without contrast.Impression: compared to (b)(6) 2014 there was decrease in size of mass like area off opacity in the posterior inferior right upper lobe now measuring approximately 4.9 cm x 3.5 cm x 2 cm, compared to 5.8 cm x 4.9 cm x 3.6 cm.This may reflect improving pneumonia.Grossly stable mediastinal and right hilar lymphadenopathy; pulmonary emphysematous disease.Patient also underwent lung perfusion scan.Impression: low probability of pulmonary embolism.On (b)(6) 2014: patient underwent x-ray of chest.Impression: stable right upper lobe mass with mild adjacent atelectasis; old granulomatous disease.On (b)(6) 2014, (b)(6) 2015: the patient presented with pain in his shoulder blades.On (b)(6) 2014: patient underwent ct of chest without contrast.Impression: there was marked interval improvement in serration of the right lower lobe with minimal atelectasis remaining in the posterior right mid lung; pulmonary emphysematous disease; slight interval decrease in size of the previously noted mediastinal lymphadenopathy, this measures at the upper limit of normal size currently.On (b)(6) 2014: the patient underwent radiographic exam due to arm pain.Impression: minimally displaced mid-left clavicular shaft fracture.Tubes and catheters appears in adequate position.Suspected small left apical pleural separation.Postsurgical changes/hardware evident in the cervical spine.On (b)(6) 2014: the patient underwent radiographic exam due to injury in shoulder, upper arm due to trauma fall.Impression: stable comminuted left clavicular fracture.On (b)(6) 2014: the patient was hospitalized due to traumatic fall.On (b)(6) 2014: the patient underwent x-ray of left shoulder.Impression: there is a stable midshaft fracture of the left clavicle.No bony callous is observed.On (b)(6) 2014: the patient underwent x-ray of right shoulder due to fall.Impression: stable right clavicular fractum.On (b)(6) 2015: the patient presented for respiratory issues.On (b)(6) 2015, (b)(6) 2016: the patient presented for follow up on limited range of motion.On (b)(6) 2015: the patient presented for follow up for injuries due to traumatic fall.On (b)(6) 2015: the patient underwent mri of right knee.Impression: marrow edema involving the medial proximal tibial plateau.Articular cartilage loss involving the medial patellofemoral joint compartment.Small right knee effusion with subpatellar extension and plica.Subtle tear involving the posterior horn of the lateral meniscus.This extends to the inferior articular surface.Adjacent degenerative subchondral cyst formation was noted.The posterior horn of the medial meniscus is attenuated, probably due old post traumatic changes.A small tear involves the posterior horn of the medial meniscus extending to the inferior articular surface.On (b)(6) 2015: patient underwent ct guided lumbar puncture with injection of intrathecal myelographic contrast material.Impression: successful ct-guided lumbar puncture at the t9 level with injection of intrathecal myelographic contrast material.Patient also underwent ct myelogram lumbar spine due to lumbago.Impression: evidence of extensive posterior cervical fusion and decompression, without ct evidence of hardware complication.No definite lumbar spinal stenosis or neural foraminal narrowing.Atrophic left kidney.Multifocal areas of right renal parenchymal scarring.Patient also underwent ct myelogram of thoracic spine due to back pain.Impression: evidence of prior thoracolumbar posterior spinal fusion, without ct evidence of complication within the thoracic hardware.Multilevel areas of neural foraminal narrowing.At least moderate if not moderate to severe centrilobular emphysema.Severely atrophic left kidney.Multifocal area of right renal parenchymal screening.
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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) 2010: patient presented for management of acute renal failure.Impression: acute renal failure; chronic hypertension; severe degenerative joint disease; chronic depression; anxiety disorder; chronic tobacco and alcohol use.Patient also underwent ultrasound of kidneys.Impression: mild prominence of the right renal pelvis as well as dilation of the proximal right ureter; foley catheter in place.Patient also underwent x-ray of chest.Impression: mild blunting of the right lateral costophrenic angle; no focal consolidation; postoperative and degenerative changes of spine.On (b)(6) 2010: patient presented with pre-op diagnosis: chronic pain syndrome.For which patient underwent pump for intrathecal analgesic.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2011: patient presented with complaint of neck and back pain that worsened.Diagnosis: cervicalgia; cervical spondylosis without myelopathy; thoracic pain; lumbar spondylosis; chronic pain syndrome.
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Event Description
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It was reported that on: (b)(6) 2008: patient underwent spine radiography, portable lumbar spine single view.Findings: increased lumbar lordosis has been created centered at l2-3.The l4-5 and l5-s1 anterior fusion procedures with metallic bone cages are unchanged.Severe degenerative disc diseases persist at l3-4.On (b)(6) 2008: patient underwent chest radiography.Findings: patient is status post cervical spine anterior fusion.Thoracolumbar spine fusion rods are also in place.Lung volumes are small.Bibasilar atelectasis has internally developed, patchy air space opacity seen in left upper lobe.Marked gaseous distention of stomach.Impression: filling defects in segmental arteries of right upper and right lower lobes, suspicious for pulmonary embolism.Bilateral lower lobe atelectasis with small bilateral pleural effusions.Bilateral patchy ground glass opacities is of unknown etiology.On (b)(6) 2008, the patient presented for lower extremity venous doppler due to chest pain.On (b)(6) 2008, the patient presented had single view abdomen examination.Findings: the nasogastric tube tip is obscured by the patient's spinal fusion device.However, it appears to reside near the gastroesophageal unction with proximal sidehole located in the esophagus.Gas is seen within multiple minimally distended loops of small bowel with gas in large bowel loops, most consistent with ileus.The pelvis is excluded from this study.Post surgical changes seen of spinal fusion with paired posterior rods.The visualized lung bases are clear.On (b)(6) 2008, patient underwent chest radiography.Findings: small lung volumes.No pleural effusion identified.On (b)(6) 2008: patient assessment revealed: patient is progressing towards goal as evidenced by: decreased assistance required with mobility.Increased distance of ambulation.Improved activity tolerance.Improved gait pattern.Patient underwent spine radiography, thoracolumbar spine scoliosis standing.Impression: interval revision posterior spinal fusion procedure from t9 to s1 with subtotal l3 corpectomy.Unchanged anterior discectomy and fusion from l4-s1.Mild degenerative disc disease of thoracic and lumbar spine.On (b)(6) 2008: patient discharged from the hospital.On (b)(6) 2008: patient underwent spine radiography.Indication: scoliosis.Impression: instrumented posterior fusion procedure from t9 through s1, unchanged.Instrumented anterior fusion procedure at l4-5 and l5-s1, unchanged.Normal alignment of thoracic and lumbar spine; status post l3 pedicle reduction osteotomy.On (b)(6) 2008, the patient presented for follow up on chronic neck and back pain.On (b)(6) 2008 the patient called and reported a lot of pain in mid-thoracic area.On (b)(6) 2008 the patient was presented for office visit with intermittent trouble urinating, some mid thoracic back pain which is at the top of the incision.It was a little bit more on the right, but is also bilaterally.X rays images of spine showed overall excellent alignment.Impression: thoracic myelopathy status post discectomy with fixed sagittal imbalance-status post t9 to ilium fusion with l3.On (b)(6) 2008 the patient called and reported experiencing leg swelling and c/o of back pain.On (b)(6) 2008 the patient was presented for office visit with four months postop.The patient reported bilateral mid lumbar back pain which seems to be radiating bilaterally.He underwent x ray of the spine which showed thoracic myelopathy status post discectomy with fixed sagittal imbalance status post pedicle substraction osteotomy (l3).On (b)(6) 2008:patient underwent spine radiography.Impression: t9-s1 posterior spinal fusion, unchanged.No evidence for instrumentation failure.L4-s1 anterior spinal fusion, unchanged.C6-t1 anterior spinal fusion, unchanged.No evidence for instrumentation failure.Status post l3 pedicle reduction osteotomy.On (b)(6) 2008: patient presented for office visit.On (b)(6) 2009 the patient reported that his myelogram was unsuccessful.Patient was in excruciating pain lying on stomach and didn't want to continue.On (b)(6) 2009 the patient was presented for office visit with thoracic back pain.Impression: myofascial pain- thoracic just below right of his surgical scar.On (b)(6) 2009 the patient was presented for office visit with back pain.Impression: overall better with tpi's, physical therapy.On (b)(6) 2009 the patient was presented for office visit with upper lumbar back pain.Impression: myofascial pain associated with lumbar surgical tear.On (b)(6) 2009 the patient was presented for office visit with thoracic back pain, radiating pain in left leg, numbness in right foot.On (b)(6) 2009, the patient presented with thoracic back pain , radiating pain , numbness right foot.Diagnostic impression: status post lumbar fusion.Status post thoracic fusion.Thoracic pain.Post laminectomy syndrome.On (b)(6) 2009 the patient was presented for office visit with low back and bilateral lower extremity pain; neck pain and upper extremity pain.The patient described a constant achy pain in his low back with radiation to both lower extremity.He also described generalized extremity weakness.He reported numbness in both feet right greater than the left.He also reported neck stiffness.Diagnostic impression: status post lumbar fusion.Status post thoracic fusion.Thoracic pain.Post laminectomy syndrome.Lumbar spondylosis.Thoracic pain.On (b)(6) 2009: the patient underwent lumbar spine radiography, spine lumbosacral 2 or 3 views.Impression: posterior spinal fusion procedure from t9 through s1 and anterior fusion procedures l3-s1 without evidence of implant failure with solid bony bridging.Pedicle reduction osteotomy l3.On (b)(6) 2009: patient presented for office visit.
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