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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Muscle Spasm(s) (1966); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Stenosis (2263); Joint Swelling (2356); Numbness (2415); Neck Pain (2433)
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.
 
Event Description
It was reported that on (b)(6) 1992, (b)(6) 1993: patient presented for follow-up.Patient presented with neck pain, mid back and low back pain.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain.Musculoskeletal tension headaches.Tmj dysfunction.(b)(6) 1992: patient underwent mri of the brain.Impression: punctate area of increased signal, right cerebellar cortex, most consistent with old infarct.(b)(6) 1993: patient presented for follow-up.Patient presented with neck pain, mid back and low back pain.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain.Migraine headaches.Tmj dysfunction.Musculoskeletal tension headaches (b)(6) 1994, (b)(6) 1995: patient presented for follow-up.Patient presented with neck pain, mid back and low back pain.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibro myositis.Chronic musculoskeletal tension headaches.(b)(6) 1996, (b)(6) 1997, and (b)(6) 1998: patient presented for follow-up.Patient presented with neck pain, mid back and low back pain.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibro myositis.Chronic insomnia secondary to chronic pain syndrome.Tmj dysfunction 4) status post cervical herniated disk surgery with fusion.(b)(6) 1998, (b)(6) 1999, (b)(6) 2000, (b)(6) 2001: patient presented for follow-up.Patient presented with neck pain, midback and low back pain.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibromyositis.Chronic insomnia secondary to chronic pain syndrome.(b)(6) 2000: patient presented for follow-up.Impression: chronic neck pain, bilateral shoulder and upper extremity pain, right much greater than left.Chronic lower back and right lower extremity pain.History of cervical spine surgery x2.Radiographic evidence of cervical spondylosis with neuroforaminal narrowing at multiple levels.History of lumbar disc disease and herniated disc.History of work related injury now declared on permanent total disability as per patient's report.(b)(6) 2000: patient presented for an office visit.Impression: chronic shoulder pain, cervical spine surgery, lumbar disc disease.(b)(6) 2001, (b)(6) 2002, (b)(6) 2003: patient presented for follow-up.Patient had tenderness, swelling and nodular muscle spasm in the cervical spine, lumbar spine.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibromyositis.Chronic insomnia secondary to chronic pain syndrome.Lumbar herniated disk and probable cervical herniated disk at c4-5 and c6-7 level.(b)(6) 2003 the patient presented with the following pre-op diagnosis: chronic neck and bilateral shoulder pain, status post cervical spine fusion, post cervical laminectomy pain syndrome, bilateral cervical radiculopathy, bilateral occipital neuralgia, clinical evidence of suprascapular nerve entrapment, history of work-related injury.The patient underwent: in/out epidural catheter for cervical epidural steroid block under fluoroscopy with contrast dye.Interpretation of epidurogram, cervical.Transforaminal epidural steroid block under fluoroscopy with contrast dye, on the left at level c5 and c6.Suprascapular nerve block, on the left.Occipital nerve block, bilateral.(b)(6) 2004: patient presented with chronic tmj pain, chronic cervical thoracic and lumbosacral strain with palpable fibromyositis and cephalalgia by history lumbar herniated disk and probable cervical herniated disk at c4-5 and c6-7 level.(b)(6) 2004: patient presented for follow-up.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibromyositis.Chronic insomnia secondary to chronic pain syndrome.Chronic cervical and lumbar herniated disk, status post surgery.Cervical herniated disk at c4-5, c6-7 level.(b)(6) 2005: patient was diagnosed with lumbar listhesis with stenosis and foraminal stenosis, l4-5, lumbar stenosis, l3-4.The patient underwent: l4 gill laminectomy, decompressive, l3 to l5 laminectomy with foraminotomies, l4-5 plif, l3 to l5 fusion and internal fixation, left iliac crest bone graft, local bone graft, bone bank bone graft.As per op notes, a left iliac crest bone graft was taken through a separate fascial incision.A generous amount of iliac crest bone graft was removed.The plif was performed using the acroluled lordotic saber cage.A 13 mm x 11 mm x 25 mm lordotic cage was used.This was filled with a bmp sponge and impacted into place on the left side followed by the right side without any difficulty and with an excellent cage fit.Iliac crest bone graft was then placed lateral as well as medial to the cages and an adequate amount of bone was packed around the cages.A 13x11x25 mm lordotic cage was filled with a bmp sponge and impacted into place on the left side followed by the right side with excellent placement.A 50mm screw was used on the left at l3.At l4, a 45 mm x5.0 mm screw was used on the left and a 50mmx6.0 mm screw was used on the right.At l5, 6x 45mm screws were used bilaterally.Fusion was then performed from l3 to l6 in the transverse process region.The iliac crest bone graft was mixed with the local decorticated bone graft which was morselized and a generous amount of bone was placed in the right side due to the fact that there were only two screws on the right side.Fluoroscopy was used to confirm adequate screw placement on both ap and lateral x-rays.(b)(6) 2005: patient presented for follow-up.Patient had tenderness, swelling and nodular muscle spasm in the cervical spine, lumbar spine.Neurological impression: chronic severe cervical, thoracic and lumbosacral strain with palpable fibromyositis.Chronic insomnia secondary to chronic pain syndrome.Chronic cervical and lumbar herniated disk, status post surgery.(b)(6) 2005, (b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, the patient returns today for a follow-up and reevaluation medical problems: chronic neck and bilateral shoulder pain.Status post cervical spine fusion.Post cervical laminectomy pain syndrome.Bilateral cervical radiculopathy.Bilateral occipital neuralgia.Clinical evidence of suprascapular nerve entrapment.History of work-related injury.History of fatty liver.Myalgia neck and upper back.Musculoskeletal: there was myofascial tenderness and palpable muscle bends over the cervical paraspinous, trapezius, levator scapular muscles, upper thoracic muscles and periscapular muscles bilaterally.There is exquisite tenderness to palpation over the greater occipital nerves bilaterally.The patient underwent trigger point injections.The patient tolerated the procedure well.Reduced range of motion.(b)(6) 2006 the patient came for a follow-up post lumbar laminectomy pain syndrome.(b)(6) 2006 the patient presented with following pre-op diagnosis: post lumbar laminectomy pain syndrome.The patient underwent: insertion and tunneling of lumbar epidural catheter under fluoroscopy with contrast dye for pain management.Interpretation of lumbar epidurogram.Epidural injection of local anesthetic and opiate medication via indwelling tunneled epidural catheter.Programming of external infusion pump.(b)(6) 2006 the patient presented with following pre-op diagnosis: post lumbar laminectomy pain syndrome.The patient underwent: implantation of intrathecal catheter with tunneling of the catheter under fluoroscopy with contrast dye documentation.Intraoperative use of fluoroscopy.Intraoperative myelography with interpretation.Implantation of constant flow arrow.Pump chosen: 30 cc reservoir with one cc per day delivery rate.-pump refill.Medications used: morphine sulfate 0.5 mg for cc concentration.Total volume: 30 cc.Intrathecal bolus via the implanted intrathecal catheter.(b)(6) 2006 the patient came for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.There is a swelling at the site of the pump reservoir.(b)(6) 2006 the patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.The patient states that she has been spitting up blood.She is requesting an intrathecal bolus to be done today.Patient tolerated procedure well without any apparent complications.(b)(6) 2006, (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2013.The patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.She is requesting an intrathecal bolus to be done today.Patient tolerated procedure well without any apparent complications.(b)(6) 2008, (b)(6) 2011, (b)(6) 2013, (b)(6) 2014 the patient returns today for a follow-up and scheduled pump refill.Patient tolerated procedure well without any apparent complications.(b)(6) 2008: patient presented with follow up.Impression: patient with dysphagia for about a year.Left lower quadrant pain, diverticulosis.(b)(6) 2008, (b)(6) 2013: patient presented for an office visit.(b)(6) 2009 the patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.She was recently diagnosed with mild renal insufficiency.She is requesting an intrathecal bolus to be done today.Patient tolerated procedure well without any apparent complications.(b)(6) 2009 the patient underwent mri of lumbar spine.Diagnosis: persistent lumbar radiculopathy.(b)(6) 2009 the patient underwent mri of lumbar spine w/o contrast.Impression: no acute abnormality.There is no evidence of a fracture, marrow edema or new subluxation.Moderately severe l2-3 central and lateral recess stenosis which is multifactorial, as described above.Expected appearance after laminectomy, l4-5 disc implant placement, and posterior fusion achieved with paired pedicular screws at the l4 and ls levels and a single left-sided pedicular screw at the l3 level.The thecal sac and spinal canal from the l3 to si levels is unremarkable.There is no evidence of residual stenosis or compression of the thecal sac or nerve roots at these levels.(b)(6) 2009 the patient came today for a follow-up and scheduled pump refill.She continues to be symptomatic with back pain that radiates into both hips.Mri of the lumbar spine revealed the presence of severe lumbar spinal stenosis at the level of l2-l3 with associated multilevel lumbar disk disease and facet disease.She is requesting an intrathecal bolus to be done today.(b)(6) 2009, the patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.The patient sustained fractures of the left side of the chest.She is requesting an intrathecal bolus to be done today.Patient tolerated procedure well without any apparent complications.(b)(6) 2010 the patient returns today for follow-up and reevaluation.Musculoskeletal examination: lumbar facet maneuvers are positive bilaterally.There is multilevel lumbar paraspinous muscle tenderness with spasm with myofascial foci of the lumbar paraspinous, quadratus lumborum erector spine muscles bilaterally.There is myofascial tenderness of the cervical paraspinous, trapezius and "levator" scapular muscles bilaterally with myofascial foc.(b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014 the patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across lower back with radiation into the lower extremity.Patient tolerated procedure well without any apparent complications.(b)(6) 2010: patient presented with adjacent segment failure, l2-3 with foraminal stenosis and retrolisthesis.Procedure: left l2-l3 xlif (with interbody cage and interbody fusion); l2-l3 internal fixation (bmp, formagraft fusion).Op notes: a 12mm x 18mmx 50mm lordotic cage was filled with a small bmp kit and the formagraft and the nuvasive cage was impacted into place with an excellent fit.The internal fixation plate was impacted into the lateral vertebral bodies, followed by use of the all going.Across midline followed by placement of screws.Of note, the screw at the top of l3 when directly above the internal fixation screws at the l2-l3 level and there was only one screw as mentioned above, which was easily negotiated staying within the vertebral body for the l3 strew coming from laterally.The l2 screw was then also placed coming from laterally and top locking caps were placed and torqued in the usual manner.Good fluoroscopic confirmation of all hardware was performed.There were no complications.(b)(6) 2010 the patient returns today for a follow-up and reevaluation.She was complaining of pain of the neck with radiation into both shoulders.The patient underwent myofascial foci injection.(b)(6) 2010 patient returns today for a follow-up and scheduled pump refill.She has requested production of the intrathecal morphine therapy.Patient tolerated procedure well without any apparent complications.Diagnostic impression: myalgia of the cervical, trapezius and upper thoracic muscles bilaterally.(b)(6) 2010 the patient came for an office visit status post left l2-l3 xlif (with interbody cage and interbody fusion): l2-l3 internal fixation (bmp, forma graft fusion).She still had significant right leg pain, although her knee frequently swells up enormously due to pain.She feels like her hands are going numb (b)(6) 2010, (b)(6) 2012, the patient returns today for a follow-up and scheduled pump refill.She was complaining of pain across the lower back with radiation into the lower extremity.She was requesting escalation of the intrathecal infusion therapy.Examination of the back: there wais diffuse tenderness to palpation of the lumbar muscles bilaterally.This was especially along the laminectomy scar.Neurological evaluation: no focal sensory or motor deficit.Examination of the extremities: reveals palpable distal pulses.Patient tolerated procedure well without any apparent complications.(b)(6) 2010: patient presented for an office visit.Musculoskeletal: negative for arthralgias, edema, joint stiffness, my algias, gait strength, range of motion, atrophy gait strength, atrophy.(b)(6) 2011, the patient returns today for a follow-up and scheduled pump refill.She was complaining of pain across lower back which is aggravated by sustained upright posture.Patient tolerated procedure well without any apparent complications.(b)(6) 2011, (b)(6) 2013 the patient presented with pre-op diagnosis: chronic lower back and bilateral lower extremity pain, post lumbar laminectomy pain syndrome, status post implantation of constant flow arrow pump, rule out malfunction of implanted pump.The patient underwent: review of implanted pump and catheter under fluoroscopy, intraoperative use of fluoroscopy, injection of contrast dye via implanted pump catheter with interpretation of intrathecal myelogram, intrathecal bolus of morphine sulfate vin implanted pump catheter.(b)(6) 2011 the patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across the lower back with radiation into the lower extremity.She is requesting escalation of the intrathecal infusion therapy.Patient tolerated procedure well without any apparent complications.(b)(6) 2011 the patient presented for a reevaluation of a left l2/3 xlif (with interbody cage and interbody fusion); l2/3 internal fixation (bmp' formagraft fusion) that was performed on (b)(6) 2010.(b)(6) 2011 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast.Impression: mild disc degeneration at t71 -l2 without significant canal stenosis.Moderate to severe foraminal narrowing at l2-l3 and l3-l4 due to disc degeneration and facet arthropathy.Moderate spinal canal narrowing at l2-l3 due to disc degenerative and facet arthropathy.The patient underwent mri of cervical spine w/o contrast.Impression: post operative changes at c5 c6 as described.Degenerative disc disease at c4-c5 and c6-c7.Moderate foraminal narrowing c6-c7 and c7-tt on the right.Small central protrusion at c2-c3.(b)(6) 2011 patient returns today for a follow-up and scheduled pump refill.She recently fell and sustained fractured ribs.She is requesting an intrathecal bolus to be done today.Examination of the back: there is diffuse tenderness to palpation of the "quadratus lumborum" and erector spine muscles bilaterally.Lumbar range of motion is approximately 70% expected normal range in all planes with mild rigidity.Neurological evaluation: reveals no changes in the sensory or motor exam.Examination of the extremities: reveals palpable distal pulses.Patient tolerated procedure well without any apparent complications.(b)(6) 2011 the patient presented with the following pre-op diagnosis: post lumbar laminectomy pain syndrome; mri of the lumbar spine (b)(6) 2009: severe central and lateral recess stenosis at the level of l2 l3 secondary to disk bulge, retrolisthesis and facet disease.Multilevel lumbar disk bulge extending from t11, t12 to l3 l4.Multilevel lumbar facet disease; status post lumbar fusion; myalgia of the cervical, trapezius and upper thoracic muscles bilaterally; status post successful diagnostic facet joint nerve block.The patient underwent: intraoperative use of fluoroscopy; diagnostic/therapeutic lumbar facet joint/medial branch steroid injection under fluoroscopy with contrast dye, bilateral times six.(b)(6) 2011 the patient presented with complaint of pelvic pain.(b)(6) 2011 the patient underwent ct of abdomen and pelvis with contrast.Impression: no acute inflammatory changes or obstructive process in the abdomen or pelvis.Postoperative changes of the lumbar spine with a right lower anterior abdominal wall implant device with leads extending to the lumbar spine.Non visualization of the uterus consistent with previous hysterectomy.Several old healed left posterior fractures.(b)(6) 2011 the patient returns today for a follow-up and scheduled pump refill.She was complaining of pain across the lower back with radiation into the lower extremity.She was requesting an intrathecal bolus to be done today.Examination of the back: there was tenderness to palpation over the lumbar facet joints bilaterally.There was positive lumbar facet joint maneuvers on extension and lateral flexion.There was diffuse tenderness to palpation of the lumbar muscles bilaterally.Neurological evaluation: reveals no changes in the sensory or motor exam.Examination of the extremities: reveals palpable distal pulses.Patient tolerated procedure well without any apparent complications.(b)(6) 2011 the patient presented with the following pre-op diagnosis: post lumbar laminectomy pain syndrome; mri of the lumbar spine (b)(6) 2009: severe central and lateral recess stenosis at the level of l2 l3 secondary to disk bulge, retrolisthesis and facet disease.Multilevel lumbar disk bulge extending from t11, t12 to l3 l4.Multilevel lumbar facet disease; status post lumbar fusion; myalgia of the cervical, trapezius and upper thoracic muscles bilaterally; status post successful diagnostic facet joint nerve block.The patient underwent: lumbar facet radiofrequency "rhizotomy" under fluoroscopy guidance, on the right at the levels of l3, l4, l5, sacral ala; intraoperative use of fluoroscopy.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that (b)(6) 2012: the patient presented for office visit.The patient underwent physical examination: impression: seizers like episodes but not particularly suggestive of seizures, abnormal eeg.On (b)(6) 2012: the patient presented for office visit for follow-up of lumbar and cervical spondylosis.On (b)(6) 2012: the patient presented for office visit with complaint of radiating pain from neck to upper extremities and to lower extremities.The patient underwent physical examination: impression: electrodiagnostic study demonstrates findings of mild focal de myelination of left median short segment study of the wrist consistent with mild left carpal tunnel syndrome.Ros revealed: musculoskeletal : joint pain or stiffness, weakness, injury swelling , spasm.The patient underwent emg and ncv test: impression: abnormal study.Electrodiagnostic study demonstrates finding of mild focal slowing of left median short segment study at the wrist consistent with mild left carpal tunnel syndrome.The patient underwent spine standing scoliosis series.Impression: loosening of the l3 screw on the left with grade 1 anterolisthesis of l3 on l4, approximately 23 degree of levoscoliosis at l2-l3, osteopenia with multiple compression fractures through out the thoracic spine which are not seen well as result of the scoliosis.
 
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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 Key5182865
MDR Text Key29921196
Report Number1030489-2015-02839
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 10/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/01/2011
Device Catalogue Number7510200
Device Lot NumberM110806AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/11/2010
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 Weight64
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