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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
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)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Note(s): 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.Multiple products 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.
 
Event Description
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.Bilateral posterior segmental spinal instrumentation t9, t10, t11, t12.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.¿ 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.(b)(6) 2008, the patient presented for lower extremity venous doppler due to chest pain.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.(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 side hole 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.Patient underwent chest radiography.Findings: small lung volumes.No pleural effusion identified.(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.(b)(6) 2008: patient discharged from the hospital.(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.There was no significant central spinal canal stenosis.(b)(6)2008 the patient called and reported a lot of pain in mid-thoracic area.(b)(6) 2008, the patient presented with complaint of mid thoracic back pain.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.(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.(b)(6) 2008 the patient called and reported experiencing leg swelling and c/o of back pain.(b)(6) 2008, the patient called to complain of major mid <(>&<)> upper back pain.(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 subs traction osteotomy (l3).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.(b)(6) 2008: patient presented for office visit.(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.(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.(b)(6) 2009, the patient presented with complaint of back pain.The patient underwent trigger point injection procedure.(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.(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.(b)(6) 2009, the patient presented for physical therapy.(b)(6) 2009 the patient was presented for office visit with back pain.Impression: overall better with tpi¿s, physical therapy.(b)(6) 2009 the patient was presented for office visit with upper lumbar back pain.Impression: myofascial pain associated with lumbar surgical tear.(b)(6) 2009, the patient called and complaint of swelling middle back.(b)(6) 2009 the patient was presented for office visit with thoracic back pain, radiating pain in left leg, numbness in right foot.(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.(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.(b)(6) 2009, the patient presented with complaint of low back and bilateral lower extremity pain.(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.(b)(6) 2009 the patient was presented for office visit with 1) low back and bilateral lower extremity pain; 2) 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.(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.(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.(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.(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.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.(b)(6) 2009: patient presented for office visit.(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.(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.(b)(6) 2010 the patient called in with complaints of burning and hurting.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.(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.(b)(6) 2010 the patient was admitted with the following complaints: post obtrusive 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.(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.(b)(6) 2010 the patient was transferred to southeast missouri hospital in post obstructive diuresis.(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 time two.Fulguration of bleeding at biopsy sites.Foley catheter placement.(b)(6) 2010 the patient underwent a cystoscopy, bilateral retrograde pyelograms and bladder biopsy.Findings: film shows multiple interpedicular 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.(b)(6) 2010 the patient underwent urodynamic studies.There was no evidence of any detrusor sphincter dyssynergia.(b)(6) 2010: patient presented with pre-op diagnosis: chronic pain syndrome.For which patient underwent medtronic pump for intrathecal analgesia.Patient tolerated the procedure well without any intraoperative complications.(b)(6) 2010: as per telephonic records, patient had a lot of pain in left groin area.(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.(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.(b)(6) 2011: the patient presented for follow up of history of neurogenic bladder.(b)(6) 2011, (b)(6) 2012: the patient presented with right ankle pain.(b)(6) 2012, (b)(6) 2013: the patient presented with left shoulder rotator cuff arthropathy.(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.(b)(6) 2011: patient underwent x-ray of chest.Impression: mild right basilar fibrosis.No pneumothorax, acute focal consolidation or pulmonary edema.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5845802
MDR Text Key51111656
Report Number1030489-2016-02273
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2010
Device Catalogue Number7510800
Device Lot NumberM110708AAF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/13/2016
Initial Date FDA Received08/04/2016
Supplement Dates Manufacturer Received07/13/2016
Supplement Dates FDA Received09/24/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/06/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight83
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