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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Bone Fracture(s) (1870); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pneumonia (2011); Loss of Range of Motion (2032); Thyroid Problems (2102); Weakness (2145); Tingling (2171); Discomfort (2330); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
It was reported that (b)(6) 2004: patient underwent mri of lumbar spine due to lbp and bilateral lower extremity radicular pain and numbness and tingling worse on the left.Compression fractures arc seen at tile l1 level and to a lesser degree at ti2.These compression fractures appear chronic.There was no stenosis, retropulsion of bone into the canal or other focal-specific abnormality.(b)(6) 2007: patient presented with lumbago.(b)(6) 2007: patient presented with low back pain with right buttock and lower extremity pain.Patient had complaints of right lower extremity weakness.Patient had complaints of bowel/bladder dysfunction.Pain increases with standing, sitting, extension, recumbency, bowel movement, and transitions.Patient was positive for incontinence.Patient had bowel times three, bladder times two, and had had extreme urgency for three to four months.Review of systems: weight loss, leg numbness, muscle weakness, bowel/bladder control problem, severe nighttime pain, change in appetite, poor sleep, leg swelling, depressed, hypersensitivity, and thyroid problem.Physical examination: patient had marked tenderness to palpation to lower lumbar spine and thoracolumbar spine.Patient had low back pain with heel walking.Patient had an unsteady gait.Diagnosis: 1.Compression fracture of t12 and l1 2) thoracolumbar pain.Roentgenographic exam: lumbar mri - (b)(6) 2004: there was compression fracture of t12 and lion the sagittal films.There was normal signal intensity of the bone indicating that the fracture was likely to be remote.There were degenerative changes of the disc at t11/12, t12/l1, and l1/2 which appears to be related to the vertebral body fractures at those levels.The discs at l2/3, l3/4, l4/5, and l5/s1 appear healthy without degenerative changes.There was no significant neurologic compression in the lumbar spine.4 views of lumbar spine: there was a remote compression fracture of t12 and l1 with advanced degenerative changes of the disc t11/12 and t12/l1.There was approximately 50% height loss of l1 and 25% of t12.No instability on flexion/extension.Normal coronal plane alignment.There if kyphosis at the thoracolumbar junction secondary to the vertebral fractures.Diagnosis: 1.Compression fracture of t12 and l1 2.Thoracolumbar pain.02/19/2007: patient underwent mri scan of thoracic and lumbar spine with history of mid back pain, low back, and right leg pain, and paresthesias of the left foot.Conclusions: 1)there was an area of syringomyelia of minimal diameter of 2 mm extending from mid t6 through mid t9.2) mild loss of anterior vertebral body height of t12, and there was a large schmorl's node in the superior plate oftl2.3) no cord compression or neural foraminal stenosis was noted.4) old stable compression fracture, l1.5) minor anterior disc bulges, l1-2 through l3-4.6).No posterior disc herniation or bulge was noted, and the lumbar spinal canal and neural foramina remain of adequate caliber at all levels.(b)(6) 2007: patient presented for visit.Assessment: htn, copd (b)(6) 2007: patient presented for pre-op evaluation.Pre-op evaluation: based on the patients history, physical exam and ekg, the patient should be a low risk cardiovascular candidate for surgery.Patient underwent ap chest radiograph due to hypertension.Impression: 1) no evidence for acute cardiopulmonary process 2) age-indeterminate compression deformity of upper lumbar vertebral body, probably l1.Pain was worse with activity coughing, lying on side with knees bent.(b)(6) 2007: preop testing demonstrates that her diabetes was poorly controlled.It was recommended to delay the surgery until her diabetes was under better control.(b)(6) 2007: as per follow up letter ".She was seen on follow up yesterday for uncontrolled diabetes.Fortunately, her diabetes was now under excellent control.Her diabetes was adequate for surgery.She also had hypertension which was treated with medication.Her blood pressure was adequate for surgery." (b)(6) 2007: patient presented with thoracic spine pain.Neurological physical examination reveals tenderness to palpation over the thoracic spine with some kyphotic posturing in her thoracic spine.A plane ct of the thoracic spine and plane film x-rays show thoracic spine fractures.Assessment: two compression type fractures of thoracic spine patient also presented with following pre-op diagnosis: thoracic fracture (t12), lumbar fracture (l1) , kyphosis and back pain and following procedures were performed: posterior spinal fusion (t11 through l2) with instrumentation, open treatment thoracic fracture (t12), open treatment lumbar fracture (l1), segmental spinal instrumentation, iliac bone graft harvest from the left posterior iliac crest, correction of kyphosis, t11 through l2.Per op notes".Pedicle screws were placed bilaterally at t11, t12, l1, and l2.All of the screws were placed under fluoroscopic control and the position of the pedicle screw was checked in the ap, lateral and oblique projections.The t11, t12, and l1 levels were filled with 7.0 pedicle screws and the l2 level was filled with 6.0 x 40 screws.All the screws were connected.Rods were placed and the locking mechanism was engaged.The torque/counter-torque device was used to tighten the construct down to the manufacturer's recommended torque.A cross-link was placed between the t12 and l1 pedicle screws.Decortication of the laminae, transverse processes, and pars of t11, t12, l1, and l2 was performed.Bone was also placed in the inner transverse space between l1 and l2.The bmp, which had been soaked for the manufacturer's recommended length of time, was also packed with the local bone and then placed into the lateral gutters bilaterally.The deep drain was placed.A cross-link was placed and the fascia was closed with 0 vicryl, 2-0 vicryl, and 3-0 monocryl for the skin layer.Sterile dressings were applied.The drain was connected to self-suction.Following implants were used: laguna pedicle screw system (screws, locking nuts, crosslink and straddler) along with bmp.On postoperative day #1: patient complains of pain at her incision site.On postoperative day #2: the patient had svt overnight, moved to telemetry.On postoperative day #3: she had some itching at her crest area.(b)(6) 2007: patient was discharged.(b)(6) 2007: patient presented with lumbago (also 805.2 and 805.4) and underwent thoracic spine x-rays ap/lat.(b)(6) 2007: patient complains of severe discomfort.Pain was worse with activity, hard chair and bending to brush teeth.Patient reports to use walker and had abnormal gait.(b)(6) 2007: patient presented for follow -up visit.Patient had some back complaints.Roentgenographic exam: ap/lateral of thoracolumbar spine: t11-l2 posterior spinal fusion.There was slightly increase thoracic kyphosis secondary to the fracture.Pedicle screws were in good position.Diagnosis:1.Status post t11-l2 posterior thoracolumbar fusion with instrumentation and iliac crest bone graft on (b)(6) 2007 2.Compression fracture of t12 and l1 3.Thoracolumbar pain.Pain was worse with bending to brush teeth, coughing, riding in car.(b)(6) 2007: patient presented with lumbago and underwent following injections: injection major point, celestone, marcaine and xyloca ine/lidocaine.Patient had complaints of left side buttock hip pain that radiates down the outer region of her leg.Patient had tenderness to palpation to her left hip.Patient underwent left trochanteric bursae injection.(b)(6) 2007: patient presented with closed fracture of dorsal, lumbago and enthesopathy of hip region and underwent following injections: injection major point, celestone and xylocaine/lidocaine.Patient underwent mri of lumbar spine with or without contrast.Impressions: 1) thoracolumbar fusion procedure, new since prior myelogram here on (b)(6) 2007.2) no compromise of the volume or caliber of the lumbar spinal canal or neural foramina was identified.3) old compression fracture, l1, stable.4) very minor superior plate compression fracture, t12, old and stable.(b)(6) 2007: patient presented for follow-up from completion of lumbar mri.Patient had complaints of spasm that radiates from her lower back to upper back more right sided.Patient also had complaints of right lower extremity weakness.Physical exam: patient had tenderness to palpation to her right hip.Diagnosis:1.Status post t11- l2 posterior thoracolumbar fusion with instrumentation and iliac crest bone graft on (b)(6) 2007 2.Compression fracture of t12 and l1 3.Thoracolumbar pain 4.Left trochanteric bursitis.Patient underwent right trochanteric bursae injection.From (b)(6) 2007 patient presented for physical therapy 5 times which included therapeutic exercises and manual therapy exercises.(b)(6) 2007: patient presented for office visit.Reportedly patient had trouble sleeping.(b)(6) 2007: patient presented for physical therapy with pain, limited rom, weakness, functional mobility limitation and displays poor body mechanics.(b)(6) 2007: patient presented for office visit due to flu.Assessment: chronic neck pain, htn.(b)(6) 2007: patient presented with following diagnosis: 1.Status post t11-l2 posterior thoracolumbar fusion with instrumentation and iliac crest bone graft on (b)(6) 2007 2.Compression fracture of t12 and l1 3.Thoracolumbar pain 4.Left trochanteric bursitis.Patient reports that she had had a couple of falls.Patient had complaints of right leg pain and balance problems.Patient says her legs will not hold her up.Patient says that her pain pulls to her right side.Patient was depressed and was having suicidal thoughts.(b)(6) 2008: patient presented for psychological evaluation and consultation.Per report".In (b)(6) 2004, patient slipped from stairs and was injured.Doctor shaw commented nothing was broken after performing x-rays and continued her on pain medications.She then underwent spinal fusion at t11-l1.Patient reported improvement in mid back pain but pain in her low back and legs were described as worse.Patient was extremely fearful of re-injury and was limiting his activities due to this.She complains of weakness and numbness in her legs.Pain radiates down both legs and she indicates she had fallen t times.Pain was made worse by bending, lifting, leaning, lying on her side or a hard chair.Doctor reiterates that her overall state of psychological distress and overwhelmed coping was not only leading her to magnify her physical complaints, but seriously compromises her ability to cooperate with medical treatment and mobilize her personal resources." diagnostic impressions:1) major depressive disorder, single episode, severe 2) psychological factors affecting physical conditions classified elsewhere 3) severity of psychosocial stressor: 4 - severe: ongoing effects of on-the-job injury producing disruption of personal and vocational functioning.4) moderate psychological symptoms with moderate impairment of daily functioning.Problem/critical issue list: 1) moderate to severe pain 2) high levels of psychological distress 3) severe depression and anxiety 4)very high level of hydrocodone intake with inadequate pain control 5) high levels of somatic over-concern and somatization (b)(6) 2008: patient presented for office visit for checkup and complains of burning when urinating.Assessment: chronic low back pain.Patient presented with annual screening ad was recommended mammography screening.(b)(6) 2009: patient case was closed as a treatment dropout.(b)(6) 2009: patient presented for follow up for results of lab.(b)(6) 2009: patient presented for follow up visit.Assessment: htn, hyperlipidemia, chronic back pain.(b)(6) 2009: patient presented for follow up visit.Patient had fallen several times.(b)(6) 2009: patient presented with chronic back pain.(b)(6) 2009: patient underwent mri of lumbar spine without contrast due to chronic back pain.Impression: 1) pedicle screw placement, t11, t12, l1and l2 for old anterior compression fracture of l1.2) minimal facet joint degenerative changes at l4-5 and l5-s1 levels.3) lumbar mri study otherwise normal (b)(6) 2009: patient presented for office visit for evaluation to receive (b)(4).Assessment: generalized anxiety disorder, depression.(b)(6) 2010: patient presented for visit due to lbp and pain on urination.Assessment: type 2 diabetes, chronic back pain, anxiety, htn.(b)(6) 2010: patient presented for follow-up for questions about medication.(b)(6) 2010: patient presented for follow-up and complains of weakness.Assessment: right lung pneumonia.(b)(6) 2010: patient presented with copd, persistent cough, fatigue and was recommended ct scan chest with contrast.(b)(6) 2010: as per pulse oximetry test report of (b)(6) 2010 and (b)(6) 2010 showed sp02 was less than 88% for 13.8% and sp02 was less than 89% for 20%.Testing was performed on room air.She had been prescribed oxygen 2l via nc continuous but was unable to afford the oxygen secondary to not working and disability." (b)(6) 2011: patient presented for an office visit due to shoulder pain and was requested x-ray of left shoulder.Assessment: copd, chronic fatigue (b)(6) 2011: patient presented for follow up on blood sugar.Assessment: copd, type 2 diabetes, low back pain.(b)(6) 2011: patient presented for follow up on copd, type2 dm, lbp, htn and hypothyroidism.Assessment: insomnia, copd, ddd, uncontrolled dm type 2.(b)(6) 2011: patient underwent mri of lumbar spine without contrast due to lumbar radiculopathy.Impression: 1.Previous healed and posteriorly fixated compression fracture of the l1 vertebra with some associated disc: bulging at l1-2.2.The remainder of the lumbar spine was otherwise unremarkable.3.There was no significant interval change since the previous study from (b)(6) 2009.(b)(6) 2011: patient presented for visit and complains of back pain and both legs, tire easily.(b)(6) 2011: patient presented with bilateral leg/foot pain and was requested bilateral arterial doppler.(b)(6) 2012: patient presented for office visit.(b)(6) 2012: patient presented for office visit and complains of back pain.Assessment: copd, htn, ddd, hypothyroidism.(b)(6) 2012: patient underwent screening bilateral mammogram and bone density scan.(b)(6) 2012: patient presented for office visit and complains of right side back pain, radiating down right leg.Right foot swollen, right heel pain.(b)(6) 2012: patient underwent x-rays of right foot due to pain.Impression: 1.Degenerative changes.2.No acute abnormalities were seen.3.Old fracture of the proximal phalanx of the fifth toe.(b)(6) 2012: patient presented for follow up visit and complains of feet /legs tingling and frequent urination.Assessment: htn, arthritis, anxiety, neuropathy, hypothyroidism.(b)(6) 2013: patient presented for follow up visit.(b)(6) 2013: patient underwent left forearm x-ray due to left wrist/forearm pain.Impression: sub acute fractures of the distal radius and ulna with sclerosis and no significant displacement.On an unknown date patient presented for visit.
 
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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
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5095608
MDR Text Key26472361
Report Number1030489-2015-02466
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
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2009
Device Catalogue Number7510400
Device Lot NumberM110604AAB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/13/2006
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) Other;
Patient Weight71
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