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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 Chest Pain (1776); Contusion (1787); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Sprain (2083); Tingling (2171); Stenosis (2263); Discomfort (2330); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
Per medical records: it was reported that on, (b)(6) 2001: patient presented for visit due to neck problem.(b)(6) 2003, (b)(6) 2006, (b)(6) 2007: patient presented with permanent diagnosis of cervicalgia, primary localized osteoarthrosis and cervical spondylosis without myelopathy.Reason for visit is back/left hip and leg pain.(b)(6) 2004: patient had a history of right ovarian cyst, chronic pelvic pain.She also admits to nausea and poor appetite due to the pain.Endometrial biopsy showed no carcinoma.Ultrasound showed a small left ovarian cyst.Patient presented due to severe abrupt weakness.Patient presented with pre-operative diagnosis of chronic pelvic pain and persistent right ovarian cyst in postmenopausal lady and following procedure is performed: total abdominal hysterectomy, bilateral salpingo-ophorectomy.There were no intraoperative complications.Patient complained of some incisional pain.Postoperative course was marked by an episode of inability to move any of her body muscles.Patient underwent ct scan of brain and cervical spine which was normal.Patient also complained of tightness in her chest , for this ekg was done which showed no changes associated with myocardial infarcation.(b)(6) 2004: patient was discharged.(b)(6) 2006: patient complains of left sided radicular pain as well as left sided numbness to her lower extremities.She has had diagnosis of ddd of lumbar spine as well as spondylolisthesis in her lumbar spine at l4-5.Pain is affecting to the point where she can hardly walk.Patient is positive for insomnia.Physical examination of lower extremities reveals range of motion to her back being approximately 50%.She has slight 3/5 weakness to her proximal hip flexors as well as her quadriceps muscle.She has sensation loss to the lateral aspect of her thigh.Assessment: degenerative disk disease of the lumbar spine, lumbar back pain and lumbar left sided radicular symptoms, spondylolisthesis at l4-5 with degenerative disc changes through out her lumbar spine.Patient was admitted to hospital with admit diagnosis of degenerative disk disease of lumbar and lumbar pain spondylolisthesis and underwent following procedure: posterior spinal fusion at l4-5 and l5-s1.Per op notes ¿¿the posterior spinous processes at l4-l5 and l5-s1 were exposed.Posterior spinous process was removed for bone graft and 5.5 x 50 mm screws were placed into the vertebral body at l4-l5 and a 3.5 x 40 mm screw was placed in the sacrum on each side.Two 5 mm rods were then added, locked into place with two cross lengths added.Decortication was performed and the area being accessible once the rods were placed and the bmp impregnated bone was then added.The wound was irrigated with saline and closed with #1 vicryl to the skin with staples on the skin.The patient was sent to the recovery room in good condition.¿ (b)(6) 2006: patient was discharged.Post operatively she has begun some assistance with physical therapy for range of motion.Diagnosis: ddd of lumbar spine.(b)(6) 2006: patient presented for office visit.X-rays show her hardware is in good position without any loosening and breakage.Diagnosis: ddd of lumbar spine.(b)(6) 2006: patient presented for office visit.She has a little breakdown in her distal wound.It looks like skin has just kind of pulled apart.Diagnosis: ddd of lumbar spine.(b)(6)2007: patient presented for evaluation of her back which has got infected and treated with levaquin which is making her sick.Diagnosis: ddd of lumbar spine mild wound dehiscence.(b)(6) 2007: patient prevented for office visit and on physical examination found to have 75 percent rom.Diagnosis: ddd of lumbar sp ine.(b)(6) 2007: patient presented for office visit.Physical exam: on exam she has bilateral para-spinous muscle spasms with pain on percussion of the iliac crest.She has pain when she tries to flex, extend, lateral bend, or rotate, with approximately 50 percent rom of the lumbar spine.X-ray: x-rays today show the hardware is in good position without any loosening or breakage with degenerative changes at l1 through s1.Diagnosis: ddd of lumbar spine.(b)(6) 2007: patient presented for physical therapy with chief complain of neck pain.Patient has a significant increased lumbar lordosis.She has poor abdominal muscular control and strength.Hip flexors slightly limited in the iliopsoas and rectus femoris.Generalized tenderness lumbar spine.Assessment: patient is referred to pt with diagnosis of low back pain.This is chronic back pain postoperatively.Physical therapy diagnosis: musculoskeletal pattern f and i.Problems: decreased range of motion.Decreased trunk strength and core strength.Back pain.(b)(6) 2007: patient presented for physical therapy.Reports pain with lying down, bending the head, difficulty trying to sleep.She describes headaches, upper back, neck and shoulder pain, bilateral radicular symptoms, right low back pain, right posterior leg pain down to the foot.Primary complaint of neck pain and stiffness worse in the morning.She is using cervical pillow but does not report any help with that.She reports some occasional numbness right upper extremity all the way down to the hand and does have some weakness noted in the right grip.X-rays reveal anterior cervical disk fusion c3-6.Palpation: exquisite tenderness in the suboccipital, para-cervical and upper trapezius musculature with trigger points noted in the upper trapezius, levator scapula and suboccipital region.Range of motion is diminished.Positive vertebral distraction.Physical therapy diagnosis: musculoskeletal pattern d, i and b.Problems: decreased range of motion.Neck pain.Trigger points and spasm.Impaired posture.(b)(6) 2007: patient presented for office visit.Patient complains of spasms a night mostly down her leg and keeps her from sleeping.Diagnosis: ddd of lumbar spine muscle spasms (b)(6) 2007: patient presented for evaluation of her back.Four views of the lumbar spine show degenerative lumbar disc disease at l1-2 with the hardware in position without any loosening or breakage.Impression: 1.Ddd of lumbarspine.(b)(6) 2007: patient presented for injection.On exam she has some pain across the iliac crests and down in both legs through the buttocks.Impression: ddd of lumbar spine.(b)(6) 2008: patient presented with cervical and lumbar pain.Patient reports that she slipped on floor and was diagnosed with a closed head trauma and no broken bones were noted.Patient complains of continued discomfort.Patient reports that she hurts in her lower extremity on the lateral aspect of her proximal one-third of her anterior compartment of both legs.She admits spasm, decreased range of motion in her cervical and lumbar spine, difficulty sleeping, and performing daily activities.Physical examination: she has diffuse tenderness, mild resting spasm, and a paracervical musculature, and trapezial musculature.She has some mild tenderness over her sacroiliac joints.X-rays: x-rays of cervical show previous anterior cervical fusion.The hardware is intact and properly positioned.There is no evidence of loosening or obvious fracture or dislocation is noted.The cervical spine is well aligned.Lumbar x-rays demonstrate again hardware is intact and properly positioned with no evidence of loosening.No obvious fractures or dislocations are noted.Lumbar spine is well aligned.Diagnoses: sprain/strain cervical.Sprain/strain lumbar.(b)(6) 2008: patient presented for office visit and complains of having pain in both the shoulders.X-rays: x-rays of her shoulder showed ac joint arthritis.Impression: ddd of lumbar spine contusion of shoulders.(b)(6) 2008: patient underwent mri of brain without contrast due to headaches and right sided numbness.Impression: normal mri examination of the brain.2.Partial empty sella, a normal variant.(b)(6) 2008: patient presented for office visit.Patient complains of still having a lot of pain in the right shoulder, right arm, her right side, right hip, right femur and tibia.Impression: 1.Contusion of right shoulder 2.Contusion of right side.(b)(6) 2008: patient presented for evaluation of her neck.X-rays: x-rays today show the hardware is in good position without any evidence of loosening or breakage with degenerative changes at the base of her fusion area.Impression: degenerative joint disease cervical spine.(b)(6) 2008: patient presented with complains of lumbar and cervical pain.She gets migraine headaches.X-rays of her cervical and lumbar spine show her plate is in good position in the cervical spine with no evidence of any loosening or breakage.She has degenerative changes in the lumbar spine at l5-s1.Impression: djd of cervical spine and ddd of lumbar spine.She was given 30 of toradol and 40 of depo-medrol today.She was given neoprene sleeve for each knee.Impression: 1) djd of cervical spine.Dod of lumbar spine.(b)(6) 2008: patient presented for evaluation of her back.X-rays: x-rays of her lumbar spine show degenerative lumbar disc disease at l5-s1.Impression: ddd of lumbar spine.(b)(6) 2008: patient presented for office visit.(b)(6) 2009: patient presented for office visit.X-rays: four views of her lumbar spine show diffuse degenerative changes with the hardware in good position.(b)(6) 2009: patient returns today with low back pain and left and right knee pain.She carries a diagnosis of degenerative arthritis in both knees.Physical exam: on exam she has 1+ crepitus with no medial, lateral, anterior, or posterior instability.On examination of her back she complains of pain over the iliac crests and down both legs.Impression: ddd of lumbarspine 2) djd of both knees.(b)(6) 2009: patient presented for office visit.On measurement there was 1 cm difference between length of two legs.Patient was x-rayed today.X-rays show degenerative lumbar disc disease with no change from the previous x-rays.Impression: ddd of lumbar spine.(b)(6) 2010: patient presented for office visit for follow up on her right thumb.She slapped her thumb in the door and is having pain because of the nail.X-rays: x-rays are normal.(b)(6) 2010: patient presented for office visit.Physical exam: she continues to use her crutch.She has a well-healed scar from a previous surgery, with a slightly positive straight leg raise bilaterally.X-rays: x-rays show her hardware is in good position at l4-5 and l5-s1.The fusion appears to be solid.Impression: ddd of lumbar spine.(b)(6) 2010: patient presented for office visit.Her medications seems to be holding her.X-rays: x-rays today show the hardware is in good position at l4-5 and l5-s1.There appears to be no loosening, and the fusion appears to be solid.(b)(6) 2007,(b)(6) 2009 ,(b)(6) 2010, (b)(6) 2009,(b)(6) 2010: patient complained of lumbar pain and got 40 depo medrol <(>&<)> 60 toradol im right hip.(b)(6) 2010: patient presented today complaining of severe neck pain, pain that radiates up into her head and pain in her back that radiates down both legs.Physical exam: she has a positive straight leg raise bilaterally.X-rays: x-rays show the hardware is in good position.The hardware in her neck is in good position also, with some degenerative changes below her plate.(b)(6) 2010: patient t mri of cervical spine due to severe cervical pain with radiation to the head and pain in the back with radiation to the legs.Patient complains of earaches, swallowing, shortness of breath impression: multilevel fusion.Disk protrusions with contact and flattening of the ventral spinal cord surface at c2-c3, c3-c4, and c6-c7.There is foraminal compromise secondary to concomitant uncovertebral joint hypertrophy.(b)(6) 2011: patient presented for office visit.Mri scan of the cervical spine is reviewed which pretty clean.She was given an injection with 30 mg of toradol and 40 mg of depo-medrol today.(b)(6) 2011: patient underwent lumbar myelogram due to lumbago which reveals pedicle screws in place with normal alignment.Ct demonstrated what appears to be diffuse spinal stenosis.(b)(6) 2011: patient presented for office visit.She complains of cramps in both calves.Patient underwent lower extremity venous study.Conclusion: no evidence of deep venous thrombosis, no significant venous insufficiency.(b)(6) 2011: patient presented for office visit.X-rays on her back today which shows the hardware in good position without loosening or breakage.Impression: spinal stenosis.(b)(6) 2011: patient presented for office visit.Patient reportedly fell and hurt her right side down her right leg.She is walking with a cane today very slowly.I cannot get her to flex, extend, laterally bend, or rotate.X-rays of her back showed no change in hardware.Impressions: contusion of the lumbar spine.Patient was given 30 of toradol and 40 of depo-medrol today.(b)(6) 2011: patient presented for physical therapy with a diagnosis of low back pain, lumbar degenerative disk disease, lumbar radiculopathy.Primary complaint: back pain and bilateral leg pain which is radicular in nature.Pain is worse with bending, standing, walking, and worse in the morning and evening time.She has difficulty sleeping due to her back pain.She does have some difficulty with her bladder and with her gait.She reports the pain is worse in her right leg than her left leg.She does have some tingling in toes 1 and 2 and some weakness in her feet.Review of x-rays show a lumbar fusion l4-5 and s1 with instrumentation.Her gait is antalgic with decreased stance phase on the right lower extremity.Range of motion is limited.Palpation revealed tenderness in the lumbosacral region, pyriformis musculature, sciatic notch, si joints, and lumbar paraspinous musculature with general palpable atrophy lumbar paraspinous musculature.Assessment: lumbar degenerative disk disease.Lumbar radiculopathy.Low back pain.Physical therapy diagnosis: musculoskeletal pattern f and i.Problems: decreased range of motion.Decreased core strength.Back pain and leg pain.Inability to perform adls of choice.Difficulty with gait.(b)(6) 2011: patient presented for physical therapy and complains that her legs hurt worse than his back.(b)(6) 2011.Patient presented for physical therapy.(b)(6) 2011: patient presented for office visit.Her ct myelogram which does not show any impingement.Impression: low back pain.(b)(6) 2011: patient presented for office visit after a fall on her right hip and has notes hip pain since that time.On physical examination, she does have a rash on the lateral aspects of her upper arm and elbows.She has pain with internal and external rotation although not severe in nature.She has some deep palpation pain of her right hip.She has good active range of motion to her hip.X-rays: x-rays, two views of the hip, show an osteoporotic pattern to her right hip versus avascular necrosis.It does not show a fracture in the femoral neck.There is some mild glenohumeral arthritis pattern.Impression: right hip pain.Osteoporosis.Patient underwent dexa bone density scan.(b)(6) 2011: patient underwent ct of thorax without contrast due to history of lung disease and shortness of breath.Impression: mild bullous disease apices.Probable mild cylinder basilar bronchiectasis.No interstitial lung disease visible.(b)(6) 2011: patient presented for evaluation of her back.She had a bone density scan which indicates she does not need to take calcium supplement.Impression: osteoporosis.Degenerative joint disease of the lumbar spine.She was given 30 of toradol and 40 of depo-medrol today.(b)(6) 2011: patient presented for office visit.Patient reported that she tried to go back to work but failed due to pain in her back, legs and knees.Radiographs: she had x-rays, four views of her lumbar, showing her l4 to s1 fusion, unchanged.Diagnosis: degenerative disk disease, lumbar spine.Degenerative joint disease, bilateral knees.Osteoporosis.(b)(6) 2011: patient presented for office visit.Patient is in severe pain in her back and both of her knees.Patient has limited range of motion of lumbar spine.She has a positive straight leg raise bilaterally and pain on flexion/extension, lateral bending and rotation.On examination of her knees today a 1+ crepitance with mild varus deformity.(b)(6) 2011: patient presented for office visit complaining of back pain and bilateral knee pain.X-rays were reviewed which shows hardware in good position without any loosening or breakage.(b)(6) 2011: patient underwent mri of tight knee due to right knee pain.Impression: horizontal partial tear posterior horn medial meniscus with a corner tear to the posterior inferior margin of the medial meniscus abutting a 6 mm parameniscal cyst to the posterior medial joint compartment.Acute on chronic strain to the acl.Mild grade-i sprain of the mcl.A small joint effusion.Heterotopic spurring of the tibial spines.Previous surgical intervention of the distal right femur.Patient underwent mri of the left knee due to the left knee pain.Impression: chondromalacia of the patella.Mild strain to the mcl.Acute on chronic strain to the acl.Slight fraying along the inner free edge of the medial meniscus with degenerative signal to the posterior horn of the medial meniscus and a corner tear to the posterior horn of the medial meniscus abutting a 3 mm parameniscal cyst.Mild degenerative truncation to the body of the lateral meniscus.(b)(6) 2011: patient for office visit after she fell on her knees and has bilateral knee pain.X-rays: x-rays today show no fractures.Her x-ray of her right knee show what appears to be an old fracture of the distal femur, but it is healed.But there are no acute changes.Impression: contusions of the knees.(b)(6) 2011: patient underwent x-ray of lumbar spine (ap and lateral) due to lumbar/lumbosacral disc degeneration.Impression: the patient refused to have the study completed.(b)(6) 2011: patient presented for office visit due to pain.X-rays done today shows hardware is in good position with no evidence of loosening or breakage.A 40/30 injection was given to patient.(b)(6) 2012: patient underwent ct of lumbar spine without contrast (l1-s1) due to lumbago.Impression: moderate circumferential stenosis at the l3-4 level with secondary to a combination of broad disc bulge and ligamentum hypertrophy.(b)(6) 2012: patient presented for office visit for evaluation.Ct scan was reviewed which showed some degenerative changes above her fusion and mild spinal stenosis.(b)(6) 2012: patient underwent epidural injections.(b)(6) 2012: patient presented for office visit with chief complaint of back pain.Examination reveals following info about the patient: pain is worsened by lifting, lying down, sitting, standing, walking.Pain is associated with bladder problems, bowel problems, tingling, weakness.Pain is described as burning, gnawing, sharp, throbbing and constant.Review of systems is positive for fatigue, night sweats, hearing loss, shortness of breath, chest pain, constipation, leg pain, frequent falling, numbness in arms/legs and trouble sleeping.(b)(6) 2012: patient presented for evaluation of the neck and back.And complains of headaches and back pain.Physical examination: neck: patient has 75 percent range of motion of cervical spine with normal distraction compression test.Lumbar spine: she has a well-healed scar from previous surgery with 75 percent range of motion of the lumbar spine.X-rays: x-ray of the cervical spine show a solid arthrodesis with hardware in good position at c3, 4, 5, and 6.There are minimal changes above her fusion site.X-ray of her lumbar spine show hardware at 4-5 and 1 with a grade i spondylolisthesis at 3-4.Compared with last x-rays no different.(b)(6) 2012: patient presented for office visit due to neck chest and abdominal pain.Review of systems is positive for fatigue, night sweats, hearing loss, shortness of breath, chest pain, constipation, leg pain, frequent falling, numbness in arms/legs and trouble sleeping.Patient reports that she was pinned between the chair arm and he chair at infirmary when she slipped.Patient was given a 40/30 injection.(b)(6) 2012: patient presented for office visit and complains of pain.(b)(6) 2012: patient presented for physical therapy with an antalgic gait for treatment of cervical and lumbar spine.The patient reports a numb, aching, tingling sensation.Her pain scale drawing shows the entire ventral and dorsal side of the right side of the body involved from the top of her head to her feet.There is delineation between right and left that is very evident.Sleeping makes her pain better.She is using a standard cane in her left upper extremity.General posture and structure: reveals a significant increase in her lumbar lordosis.Forward head posture and significant gluteal adipose which does add to her lordotic appearance.Lumbar and cervical range of motion diminished.Patient is markedly depressed.Assessment: right side lumbar and cervical pain secondary to injury (b)(6), 2012.(b)(6) 2012: patient presented for physical therapy.(b)(6) 2012: patient presented with chief complaint of wrist/hand pain.Review of systems is positive for fatigue, night sweats, hearing loss, shortness of breath, chest pain, constipation, leg pain, frequently falling, numbness in arms/legs and trouble sleeping.Patient complains of constant pain and tenderness in first dorsal component.Physical examination: neck: mild pain at extremes of range of motion; lumbar spine: she has positive tenderness diffusely in the lumbar para-spinal muscles.Right wrist: positive finkelstein, severe and positive crepitus at the ip joint with severe pain.X-rays of the right wrist show mild osteoarthritis and hypoplastic ulnar styloid.Impression: right wrist de quervain¿s chronic pain.Gerd.Chf.Non-insulin dependent diabetes.(b)(6) 2012: patient presented with difficulty with her neck, head and back.Patient reportedly fell and had sustained bruises.Patient had increased pain in her neck and abdomen and developed headaches.Physical examination revealed slightly diminished range of motion, tenderness to palpation.X-rays of her lumbar spine reveals the previously performed fusion and instrumentation at l4 through the sacrum.There is residual spondylolisthesis of l3 on 4.The construct appears to be stable with no complications noted there.The patient's cervical spine reveals a acdf of c3-4, 4-5.Construct appears to be stable.X-rays of her pelvis and right hip does not reveal any acute injuries whatsoever.Has what appears to be a focus of fibrous dysplasia in the proximal right femur.No fractures anywhere in the pelvic region or the proximal femur or hips as noted.Impression: cervical pain.Cervical strain.Cervical spondylosis post acdf.Lumbar strain.Spondylolisthesis l3 on 4.Status post instrumentation and fusion of the lumbar spine.
 
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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 Key5179616
MDR Text Key29347754
Report Number1030489-2015-02808
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
Report Date 09/28/2015
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 Catalogue Number7510800
Device Lot NumberM118008AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/28/2015
Initial Date FDA Received10/27/2015
Was Device Evaluated by Manufacturer? No
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 Weight95
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