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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 7510100 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Arthritis (1723); Chest Pain (1776); Dyspnea (1816); Edema (1820); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Paralysis (1997); Thyroid Problems (2102); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Tingling (2171); Hernia (2240); Stenosis (2263); Urinary Frequency (2275); Malaise (2359); Depression (2361); Numbness (2415)
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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 on the lumbar region of her spine from l5-s1 using rhbmp-2/acs.It was reported that the patient's post-op period was marked by severe pain, weakness, and numbness in her lower extremities.It was reported that the patient underwent a revision surgery on (b)(6) 2011, for debridement of her left l5-s1 disc space fusion mass.The patient also underwent an additional revision surgery on (b)(6) 2011, to free the exiting l5 and s1 nerve roots from bony impingement.It was reported that the patient developed pain and weakness in her lower extremity.Patient continues to suffer from an inflammatory reaction.The patient is restricted to ambulating with a cane and left foot brace.
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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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Manufacturer Narrative
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Additional information.
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Event Description
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It was reported that on, (b)(6) 2013: the patient presented with the following pre-op diagnosis: 1.Bilateral sacroiliac joint arthropathy.2.Lumbosacral pain.3.Left lower extremity radicular symptoms.4.Status post revision decompression and fusion at l5-s1.The patient underwent the following procedures: 1.Intravenous sedation.2.Fluoroscopy.3.Bilateral joint sacroiliac joint injections with steroid.No complications were reported.(b)(6) 2013: the patient presented for an office visit.Review of systems revealed back, leg (left) pain, balance problems.(b)(6) 2014: patient presented with following diagnoses: failed back surgery syndrome with chronic residuals.(b)(6) 2015: patient underwent x-ray of lumbosacral spine minimum 4 views including oblique and bending views.Impression: orthopedic hardware inferiorly.No acute process.No evidence of instability.(b)(6) 2015: patient underwent x-ray of hip complete 2 or more views unilateral right.Impression: prior lumbosacral instrumentation and fusion.Right hip arthropathy with spurring.Differential may include femoral acetabular impingement.(b)(6) 2015: patient underwent axial t2 x-ray and sagittal t2 x-ray.Impression: mild osteophytic changes in the left at l5-s1 may minimally contact the traversing left s1 nerve roots.No significant spinal canal stenosis at any level.Minimal inferior neural foraminal narrowing secondary to disc material at l3-4 and l4-5 without compromise of the exiting l3 on l4 nerve roots.
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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 per medical records on an unknown date the patient underwent ct and mri which revealed a failed fusion.On (b)(6) 2010: patient presented with back pain.Patient had the immediate onset of back pain and left leg numbness while being at work on (b)(6) 2010.Patient described it being severe and in the area of the lower lumbar spine and right si joint and radiating to the left hip, thigh and calf.Associated symptoms ¿ sensory loss (tingling left leg).Clinical impression: back pain: lumbar area with sciatica.X-rays for ls spine series showed degenerative osteoarthritis.No fractures or other acute findings are noted.Bilateral hip x-ray showed degenerative osteoarthritis.Mri of lumbar spine revealed disc protrusion on the left with nerve root impingement at l5-s1.Assessment: acute low back pain with l5-s1 partially herniated disc with left-sided radicular pain; elevated lfts; significant reflux and gastrointestinal issues; hypothyroidism; chronic anxiety; weight loss and probable malnutrition.Pre-op diagnoses: left paracentral disc herniation, l5-s1; left lower extremity radicular symptoms.Patient underwent iv sedation, fluoroscopy and l5 and s1 transforaminal epidural steroid injection on the left.No complications reported.Patient underwent chest x-ray.Impression: normal evaluation of the chest.On (b)(6) 2010: patient underwent abdominal ultrasound due to elevated liver enzymes.Impression: normal sonographic evaluation of the abdomen status post cholecystectomy.On (b)(6) 2010: patient presented with left lower extremity radiculopathy.Patient¿s mri of lumbar spine demonstrated a sequestrated herniated nucleus pulposus at l5-s1 with the sequestrated fragment sitting just caudal to the disc space posterior to the s1 body.There is dorsal displacement of the traversing s1 nerve root.Impression: sequestrated l5-s1 herniated nucleus pulposus.Patient was discharged with following final diagnoses: acute low back pain secondary to herniated l5-s1 disc; elevated lfts; malnutrition and dehydration; reflux with ongoing abdominal pain; upper respiratory infection with a possible acute sinusitis and wheezing.On (b)(6) 2010 the patient presented with the following pre-op diagnosis: left sided l5-s1 herniated nucleus pulposus.The patient underwent left sided l5-s1 micro discectomy.No complications were noted.On (b)(6) 2010 the patient presents with fairly severe radiating pain into the left buttocks and all the way down the left lower extremity with weakness in the calf musculature.Diagnosis: left-sided l5-s1 hnp.On (b)(6) 2010 the patient presented with the following pre-op diagnosis: left sided l5-s1 herniated nucleus pulposus.The patient underwent left sided l5-s1 micro discectomy.No complications were noted.On (b)(6) 2010 the patient presents today for a follow-up on a left sided l5-s1 micro discectomy.Musculoskeletal review: some slight decreased sensation numbness and tingling in the s1 dermatome on the left.Diagnosis: the patient is doing well.On (b)(6) 2010 the patient presents to today for follow-up on a left sided l5-s1 micro discectomy.The patient complains of pain and weakness in the left lower extremity.Diagnosis: slowly improving from large left sided l5-s1 herniated nucleus pulposus.On (b)(6) 2010: patient underwent physical therapy.On (b)(6) 2010 the patient presented with the following pre-op diagnosis: herniated nucleus pulposus, l5-s1; history of left l5-s1 neural foraminal impingement; ddd, l5-s1; status post micro lumbar discectomy, l5-s1, (b)(6) 2010.The patient underwent: iv sedation; fluoroscopy; left l5 and s1 transforaminal epidural steroid injections.Post-op impression: the patient came in today with clear s1 radicular pattern.Had a high level of concordance consistent with s1 radicular symptoms after injecting the s1 foramen.Had post procedure anesthetic effect.On (b)(6) 2010 the patient presents today for follow-up on a left sided l5-s1 micro discectomy.The patient complains of numbness in the left lower extremity as well as some weakness.Diagnosis: possible recurrent disc herniation l5-s1.On (b)(6) 2010 the patient underwent mri which reveals the rest of the disc herniated.Impression: l5-s1 disc herniation which has been surgically corrected leaving only a bulging portion of the annulus and epidural scar with nerve root encasement.On (b)(6) 2010 the patient presents today for a follow-up on an mri of her lumbar spine due to recurrent left lower extremity radicular symptoms.Diagnosis: rapidly progressive degeneration of l5-s1.On (b)(6) 2010 the patient presented with the following pre-op diagnosis: lumbar ddd at l5-s1 resulting in severe left-sided neural foraminal stenosis.The patient underwent: left sided hemilaminectomy and facetectomy; posterior instrumentation, l5-s1; posterior interbody fusion, l5-s1; posterolateral fusion, l5-s1.As per op notes, utilizing lateral fluoroscopy and direct anatomic visualization, appropriately sized screw was placed in each pedicle.A complete hemilaminectomy and facetectomy was performed on the left side at l5-s1.Then a posterior annulectomy was performed, and a discectomy was performed.The disk space was filled with an rhbmp-2 sponge and morselized autograft and allograft, followed by the 9 mm t-plif spacer.Once satisfied with the interbody fusion, rods were placed bilaterally, which were compressed and packing of each posterolateral gutter with morselized autograft and allograft and rhbmp-2 sponges.No complications were noted.On (b)(6) 2010 the patient presented with the following pre-op diagnosis: acute right-sided l5 radiculopathy, status post l5-s1 fusion and left-sided decompression.The patient underwent: right sided hemi laminectomy /facetectomy.As per op notes, at first the traversing rod on the right side of lumbar spine was removed to perform a complete hemi-laminectomy/facetectomy on the right side at l5-s1.Satisfied with decompression the rod was replaced on the right side.No complications were noted.Patient underwent ct scan of the lumbar spine.Impression: bilateral pedicular l5 and s1 nerve screws and plates with bony encroachment on the right l5-s1 neural foramen.Patient underwent x-ray of the lumbar spine.Impression: posterior pedicular screws and plates fusion of l5 and s1.Patient underwent x-ray of the lumbar spine.Impression: posterior fusion with pedicular screws and plates at l5-s1.On (b)(6) 2010 the patient presents today for follow-up on l5-s1 fusion performed on (b)(6) 2010.The patient has some issues with some back spasms and leg pain.Diagnosis: the patient is doing well two weeks out from l5-s1 decompression and fusion.On (b)(6) 2010: the patient underwent venous doppler lower ext.Lt.Impression: no evidence of deep venous thrombosis.On (b)(6) 2010: patient reported pain in leg and low back due to work related injury.Patient underwent physical therapy.On (b)(6) 2010 the patient presents today for follow-up on l5-s1 fusion performed on (b)(6) 2010.The patient complains of significant discomfort in her legs and severe left sided knee pain and swelling.X-rays ap and lateral views of lumbar spine demonstrate her l5-s1 fusion appears to be healing well with good bone formation in the interbody space and no evidence of loosening or failure of the hardware.Diagnosis: right knee osteoarthritis, well known with a flare secondary to left extremity neurological issues.On (b)(6) 2010 the patient presents today due to persistent pain in her right knee.Diagnosis: right knee osteoarthritis.On (b)(6) 2010: the patient presented for an office visit.The patient underwent lab tests.On (b)(6) 2010 the patient came today for follow-up on an l5-s1 posterior instrumented fusion performed on (b)(6) 2010: patient reported pain in leg and low back due to work related injury.Patient reported twisted ankle and sinus, stiff knee, fatigue as well.Patient underwent physical therapy.On (b)(6) 2010 the patient came today for follow-up on an l5-s1 posterior instrumented fusion performed on (b)(6) 2010.The patient complains of some numbness, tingling and occasional burning pains in her left leg.She has concomitant gi issues.Diagnosis: the patient is having difficulty with her l5-s1 disc level with first a herniated nucleus pulposus and subsequent advanced degeneration.On (b)(6) 2010: the patient presented with pre-op diagnosis: status post l5-s1 posterior instrumented fusion; left lower extremity radicular symptoms.On (b)(6) 2010 the patient came for a follow-up on her l5-s1 posterior instrumented fusion.Diagnosis: the patient is steadily improving.On (b)(6) 2010: the patient underwent upper gi and small bowel follow through.Impression: a gastric bypass procedure is preset there is reflux into the esophagus.Normal unimpeded emptying is present.On (b)(6) 2010 the patient came for a follow-up on her l5-s1 fusion performed in april.The patient complains on continuous left lower extremity discomfort and weakness status posts her axillary l5-s1 disc herniation.On (b)(6) 2011 the patient came for a follow-up on l5-s1 posterior instrumented fusion that has been complicated with some generalized residual radiculopathy in the left lower extremity.The x-ray examination demonstrates her l5-s1 fusion appears to be solidly healed with no motion on flexion, extensive views.Hardware is in place and intact.On (b)(6) 2011: patient reported pain in leg and low back due to work related injury.Patient underwent physical therapy.On an unknown date in (b)(6) 2011, the patient underwent esophageal hernia repair.On (b)(6) 2011: the patient underwent endometrium biopsy.There was no evidence of hyperplasia.On (b)(6) 2011 the patient presented with mild weakness in her left lower extremity involving her left ankle, numbness in her left leg.Impression: left l5-s1 radiculopathy with significant active denervation findings seen; right l5-s1 radiculopathy with minimal denervation/reinnervation findings seen.She also underwent emg and ncs examination.On (b)(6) 2011: the patient was diagnosed with lumbar pain and lower extremity weakness.On (b)(6) 2011 the patient underwent ct of lumbar spine with 3d construction; mri of lumbar spine w <(>&<)> w/o contrast.Ct opinion: p edicle screw fixation, l5-s1.There has been removal and replacement of the right pedicle screw since the previous examination as well as resection of the right l5-s1 apophyscal joint since the previous examination, and application of the left posterior bone graft material at l5-s1.Anterior extrusion of interbody bone graft material l5-s1 in a left paramedian position unchanged.Mri opinion: post-op changes at l5-s1.The possibility of some bone graft material in the left l5-s1 foramen cannot be entirely excluded.Anterior left paramedian extrusion of bone graft material placed for l5-s1 fusion which lies adjacent to the common iliac vein, but no evidence of venous thrombosis by mri.On (b)(6) 2011: the patient presented with review of all studies, back pain.She was diagnosed with failed fusion, posterolateral fusion l5-s1, pain, lower extremity weakness.On (b)(6) 2011: the patient presented for a follow up.On (b)(6) 2011: patient underwent physical therapy for work related injury on (b)(6) 2011: the patient presented with following pre procedure diagnoses: left l5 and left s1 radiculopathy; pseudoarthrosis, l5-s1; l5-s1 fusion.Procedure: intravenous sedation; fluoroscopy; selective nerve root placed, l5 and s1 on the left.On (b)(6) 2011: the patient presented for an office visit and underwent lab tests.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: spinal stenosis with claudication.The patient underwent: preperitoneal exposure of the l5-s1 vertebral space.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: failed fusion l5-s1 with left l5 and s1 radiculopathy.The patient underwent: anterior lumbar interbody fusion with a 26 x 21, 8 degree, 10 mm perimeter peek with.7 ml of rhbmp-2 and 5 ml of plus; plate stabilization using a 33 mm plate secured with 6.5 x 25 mm screws at s1 and one 6.5 x 20 mm screw at l5; additional procedure; debridement of left anterior l5-s1 disc space fusion mass adjacent to left iliac artery and vein.As per-op notes, under headlight illumination and loupe magnification, an anterior annulotomy was performed.Intra-op findings; posterior to the extra spinal fusion mass interbody graft was found clearly not fused at the inferior margin or against the s1 vertebral body.Then a 10 mm perimeter peek graft with 8 degree of lordosis measuring 26 mm wide and 21 mm deep into the l5-s1 disc space.The peek had been filled with.7 ml of rhbmp-2 as well as a small amount of progenix plus.The graft was secured then with a 33 mm pyramid plate which was secured to the 5th vertebral body and sacrum using 6.5 mm screws; they were 25 mm in length at s1, and 20 mm in length at l5.On (b)(6) 2011: the patient presented for a postoperative visit.Patient was 9 days s/p surgery.Patient's symptoms were slightly worse compared to preoperative.Assessment: failed fusion l5-s1 with residual left l5-s1 radiculopathies.Impression: positive response to directed nerve blocks.Stable s/p alif with no improvement in symptoms.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2013 the patient presented with back pain, foot pain, and leg pain.The patient was diagnosed for status post lumbar spinal fusion, lumbar radiculopathy, chronic.Musculoskeletal review: joint aches, leg weakness, muscle weakness, muscle cramps.Neurological: balance problems, numbness, and difficulty speaking, shuffling, double vision.On (b)(6) 2011: the patient underwent pathology exam of right chest due to chronic inflammation.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: left l5-s1 acute radiculopathy status post remote left- sided transforaminal lumbar interbody fusion (tlif) with instrumentation; failed fusion l5-s1.The patient underwent: revision decompression left l5-s1 nerve roots; extensive adhesiolysis, neuralysis left l5-s1 nerve roots; explanation hardware bilateral l5-s1; re-implantation of 3d tsrh transpedicular screws with bilateral inter-transverse fusion using autograft, bone graft and rhbmp-2.As per op notes, at first ap and lateral fluoroscopy views were performed prior to incision.The pedicle screws were replaced at l5 and s1 bilaterally and placed the foramen under slight distraction.The proximal portion of the previously placed graft was seen, drilled and flushed with disc space.Intra-op findings: bony spicules and calcified ligament was present that were contributing to the compression of the s1 and l5 nerve roots.The screws were placed on the right side as well; they were all 0.5 mm larger in diameter.At s1 the screws were 1 cm shorter.These were the 3d tsrh type screws.The screws were then connected to a 3.5 cm titanium rod with small offset connectors.A torque/counter ¿torque device was used to fix the screws to the rods.X-rays confirmed nice placement and length of the screws/rod complex.The intertransverse interval then was covered with one single piece of rhbmp-2 bilaterally covered by autograft morselized from the revision decompression, as well as bone graft.The patient had following complication: postoperative anemia.On (b)(6) 2011: the patient presented for postoperative follow up.On (b)(6) 2011: the patient was discharged in good spirits with improved h <(>&<)>h.On (b)(6) 2012 the patient presented with intense numbness that wraps around her left hips to her groin and all the way down to her left foot.On (b)(6) 2012 patient came for a post-op visit with considerable pain and dysfunction of the left leg in the l5 and s1 distributions.The musculoskeletal review: back pain, leg pain, joint pain and joint swelling.Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Impression: residual left s1 radiculopathy, stable s/p alif with no improvements in symptoms, stable s/p posterior decompression and fusion l5-s1.On (b)(6) 2012 the patient underwent ct of the lumbar spine with 3d construction.Opinion: interval revision of operative changes at l5-s1.Otherwise negative noncontrast ct of the lumbar spine.On (b)(6) 2012 the patient came for a follow-up visit post-op posterior decompression and revision fusion for an l5-s1 pseudo arthrosis.Recent ct shows a nicely maturing fusion and an emg shows partial healing of the left l5 and s1 nerve roots.L5 has healed completely but s1 now shows both an acute and chronic injury.The musculoskeletal review: leg pain and leg weakness.Neurological review: balance problem and numbness.Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Stable s/p alif with no improvements in symptoms.Stable s/p posterior decompression and fusion l5-s1.Impression: residual left s1 radiculopathy.On (b)(6) 2012: the patient presented with the following preoperative diagnosis: failed l5-s1 fusion with alif and posterior revision; history of left l5 and s1 radiculopathies.The patient underwent the following procedures: intravenous sedation; fluoroscopy; left s1 transforaminal epidural steroid injection with steroid.No complications were reported.On (b)(6) 2012: the patient presented for an office visit.Impression: menometrorrhagia, etiology unclear; history of endometrial polyp positive d<(>&<)>c and polypectomy.The patient underwent hysterectomy.On (b)(6) 2012: the patient was discharged with following diagnosis: menometrorrhagia; anemia of acute blood loss.On (b)(6) 2012 as per medical records, the musculoskeletal review: present-back pain, leg pain and leg weakness.Neurological review: balance problem and numbness (left leg and right ankle).On (b)(6) 2012 the patient underwent radiographic study of lumbar spine.Opinion: stable post-op changes in the lumbar spine and mild disc space narrowing at l4-5.On (b)(6) 2012 the patient presented with back pain which is mechanical in nature and radicular features in her leg pain.Musculoskeletal review: present-back pain, leg pain and leg weakness.Neurological review: balance problem and numbness (left leg and right ankle).Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Stable s/p alif with no improvements in symptoms.Stable s/p posterior decompression and fusion l5-s1.Impression: residual left s1 radiculopathy, new rle and low back symptoms.Rec.Ct/mri rule out failed fusion or asd.On (b)(6) 2012 the patient underwent ct of the lumbar spine with 3d reconstructions; mri of the lumbar spine w <(>&<)> w/o contrast due to low back pain, left leg numbness.History of fusion.Lumbar spine ct opinion: essentially stable post-op changes in the lumbar spine.Interval hysterectomy and development of a large left ovarian cyst.Lumbar spine mri opinion: tiny left lateral disc herniation at l4-5.Post-op changes.Left ovarian cyst.Otherwise negative contrast/ noncontrast mri of the lumbar spine.On (b)(6) 2012: the patient presented with posterior si joint area pain as well as persistent pain and weakness in the left lower extremity.The patient remained very emotional, crying frequently.Review of systems showed back pain, depression.Assessment: failed fusion with residual left l5 s1 radiculopathies.On (b)(6) 2013: the patient presented with the following pre-op diagnosis: bilateral sacroiliac joint arthropathy; lumbosacral pain; left lower extremity radicular symptoms; status post revison decompression and fusion at l5-s1.The patient underwent the following procedures: intravenous sedation; fluoroscopy; bilateral joint sacroiliac joint injections with steroid.No complications were reported.On (b)(6) 2013 the patient was diagnosed for low back pain and left radiculopathy.The patient underwent testing for evaluation to determine functional abilities and limitations, to determine ability to return to previous job and to determine physical abilities.On (b)(6) 2013 the patient presents today following bilateral si joint injections.The musculoskeletal reviews: leg pain, leg weakness, joint pain, joint swelling.Neurological review: balance problems, headaches and numbness.On (b)(6) 2013, (b)(6) 2012, (b)(6) 2011 the patient presented with back pain, foot pain, leg pain.The patient was diagnosed for status post lumbar spinal fusion, lumbar radiculopathy, chronic.Musculoskeletal review: joint aches, leg weakness, muscle weakness, muscle cramps.On (b)(6) 2013 the patient presented with back pain.The patient was diagnosed for lumbar pain with radiation down the left leg, myofascial pain, status post lumbar spinal fusion, and lumbar radiculopathy, chronic.Neurological exam: neurologic: normal coordination, negative romberg.Lumbar pain with radiation down left leg; myofascial pain; status post lumbar spinal fusion; lumbar radiculopathy, chronic.On (b)(6) 2013: the patient presented with following pre-op diagnosis: bilateral sacroiliac joint arthropathy; lumbosacral pain; left lower extremity radicular symptoms; status post revision decompression and fusion l5-s1.The patient underwent: intravenous sedation.C-arm fluoroscopy.Bilateral si joint injection with steroid.On (b)(6) 2013 as per medical records, the musculoskeletal review: positive for leg pain.On (b)(6) 2013: the patient presented for an office visit.Review of systems revealed back, leg (left) pain, balance problems.On (b)(6) 2013: the patient underwent lumbar myelogram with ct and 3d reconstructions due to left leg weakness, losing control of leg, bowel/bladder issues.Opinion: question shallow disc herniation at l4-5.Postoperative changes.Otherwise negative contrast plain film myelogram.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis with contrast due to left lower quadrant pain, nausea.Opinions: remote postoperative change.Otherwise negative contrast ct of the abdomen; free fluid and a left corpus luteum cyst, status post hysterectomy.On (b)(6) 2014: the patient presented for chest pain follow up.Assessment: chest pain; abnormal ecg; cad in native artery; hyperlipidemia; hypertension, benign.On (b)(6) 2014: the patient presented with following pre-op diagnosis: bilateral si joint dysfunction; lumbosacral pain; chronic lle radicular symptoms and weakness; status post decompression fusion with revision l5-s1.The patient continued to exhibit a chronic left l5 vs s1 radicular pattern with footdrop on the left.She subsequently developed symptoms on the right which radiated into the proximal thigh.The patient underwent: fluoroscopy; bilateral joint sacroiliac joint injections with steroid.No patient complications were reported.On (b)(6) 2014: the patient presented for follow up of back pain.Diagnosis: failed back syndrome.The patient had greater weakness of the left lower extremity.She had some pain at the left knee over the patella.There was clear swelling of the left knee compared to the right but no ecchymosis or temperature change.Assessment: secondary difficulties secondary to foot drop, involving the left knee.Neuropathic pain syndrome.On an unknown date in (b)(6) 2014, the patient underwent colonoscopy.On (b)(6) 2014: the patient presented with chronic lumbar hip and buttock pain.The patient was status post l5-s1 failed fusion.Preop diagnosis: bilateral sacroiliac joint dysfunction; lumbar/hip/buttock pain; chronic left lower extremity radicular symptoms with weakness; status post decompression fusion with revision l5-s1.Procedures: iv sedation; flouoroscopy; bilateral sacroiliac joint injections with steroid.No complications reported.Impression: uncomplicated bilateral sacroiliac joint injections.On an unknown date in (b)(6) 2014, the patient underwent right breast lumpectomy.On (b)(6) 2014: the patient presented with following pre-op diagnoses: s/p decompression fusion with revision l5-s1; chronic left lower extremity radicular symptoms and weakness; lumbar/hip/buttock pain; bilateral sacroiliac joint dysfunction.The patient underwent the following procedures: iv sedation; fluoroscopy; bilateral sacroiliac joint injections with steroid.No complication was reported.On (b)(6) 2014: the patient presented with knee pain.She was in a long-leg knee ankle foot orthosis.Exam of the left leg revealed diffuse atrophy.There was generalized weakness of the knee.She had tenderness to palpation along the lateral joint line of the patella tendon.Assessment: chronic left lumbar radiculopathy; djd left knee.From an unknown date in (b)(6) 2014 till present, the patient has been diagnosed with heart attack and cardiology.Since the rhbmp-2 surgery, the patient has been having the following problems: extreme pain, pain more often than before rhbmp-2 surgery, bowel/bladder incontinence, localized edema, nerve injury, osteoarthritis, paralysis, pseudocysts, radiating leg pain, foot drop, additional surgery to help/correct with problems caused by rhbmp-2, mental anguish/depression , lower left extremity weakness, and muscle spasms in lower back, gastrointestinal problems, bone growth, and non-union bone healing.She also had the following symptoms: numbness and tingling in left leg radiating down to feet; weakness in lower extremities making it difficult to walk or stand; constant lower back pain and muscle spasms; and a burning pain in left foot; constant ache in her left hip radiating down to the bottom of left foot; weakness in left ankle causing falls; bowel/bladder incontinence; mental anguish/depression; gastrointestinal issues.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records it was reported that on (b)(6) 2002, patient presented with problems in right heel.Patient reported pain in volar aspect of her right foot.On (b)(6) 2003: the patient presented for a doctor visit.The reason for visit was chest pain.On (b)(6) 2003: the patient presented for an office visit and underwent ¿egd¿ procedure.Impressions: medium hiatal hernia; chronic gastritis (b)(6) 2003: the patient presented for an office visit with an admitting diagnosis of stress and urinary continence.The patient underwent x-rays of the upper ¿gi¿.Impression: negative upper gi except for a small hiatal hernia.On (b)(6) 2003: the patient presented for an office visit and was admitted with a diagnosis of cough.The patient also underwent x rays of the chest.Opinion: negative chest.On (b)(6) 2003: the patient presented for an office visit with a bladder infection.On (b)(6) 2004: the patient presented for an office visit with a clinical history of vomiting and underwent x-rays for ¿upper gi with kub¿.Opinion: narrowing of the anastomosis b/w the gastric remnant and jejunum.On (b)(6) 2004: the patient underwent x-rays of the abdomen due to abdominal pain.Opinion: no extravasation of anastomotic stricture gastric pouch/jejunum.On (b)(6) 2004, (b)(6) 2005, (b)(6) 2008: the patient presented for an office visit.The patient underwent ¿egd¿ procedure.Impression: the esophagus appeared normal; the gastroesophageal junction appeared normal; evidence of gastroplasty in the stomach; the duodenum appeared normal; dyspepsia.On (b)(6) 2004: the patient got admitted with the admitting diagnosis of vomiting.On (b)(6) 2003, (b)(6) 2004, (b)(6) 2005: the patient presented for an office visit.On (b)(6) 2004: the patient presented for an office visit due to pre-term labor.On (b)(6) 2004: the patient presented for an office visit due to ¿rh¿ disease of pregnancy and underwent ¿ob¿ ultrasound (limited).Opinion: normal middle cerebral artery peak systolic velocity for fetal age.On (b)(6) 2005: the patient presented for an office visit due to side pain.On (b)(6) 2005: the patient presented for right sided abdominal pain and underwent ultrasound of the abdomen.Opinion: normal abdominal ultrasound; negative pelvic ultrasound.On (b)(6) 2006: the patient presented for an office visit and the reason for the visit was ¿thyroid nodules¿.The patient underwent ultrasound of the thyroid.Opinion: mild inhomogeneity of the thyroid, consistent with hashimoto¿s thyroiditis.No discrete nodules or masses identified.On (b)(6) 2006: the patient presented for an office visit due to bilateral hip pain.Assessment of patient¿s examination: lumbago.On (b)(6) 2006: the patient presented for an office visit due to abdominal pain.The patient underwent abdominal ultrasound.Opinion: negative abdomen ultrasound.On (b)(6) 2007: the patient presented for an office visit due to ¿tsh¿.The patient was diagnosed with hypoth yroidism.On (b)(6) 2008: the patient presented for an office visit due to left abdominal side pain.The patient underwent ¿upper gi w kub¿.Impression: suspect ulcer in the distal esophagus.Post anastomotic diverticulum.Spontaneous reflux to the level of carina.On (b)(6) 2008: the patient presented for an office visit due to abdominal pain and underwent ct scan of the abdomen.Finding: herniation of the small bowel brought up to anastomose with the gastric pouch through the hiatal hernia into the lower mediastinum, along with proximal gastric pouch.There is no evidence of visible ulceration.Linear foci of contrast represent infolding of gastric mucosa.The patient also underwent ct scan of the abdominal pelvis with contrast.Impression: hiatal hernia with several small ulcerations, one of which extends to the serosal surface.On (b)(6) 2008: the patient presented for an office visit due to abdominal pain and underwent hepatobiliary imaging and gbef.Impression: normal liver parenchymal function, normal visualization of the common bile duct and gallbladder, and normal emptying into the duodenum; very high ejection fraction of 91% after kinevac injection.On (b)(6) 2008 the patient was presented for office visit with epigastric pain.Assessments: epigastric pain and biliary dyskinesia.On (b)(6) 2008: the patient underwent ¿laproscopic cholecystectomy¿ with the pre-operative diagnosis of biliary dyskinesia and colic.Findings: non-inflamed gallbladder; normal-appearing extrahepatic biliary tree.Final pathologic diagnosis of the gallbladder: chronic cholecystitis.On (b)(6) 2008, (b)(6) 2009: the patient presented with ¿iron def anemia¿.On (b)(6) 2008, patient underwent x-ray of ankle which showed no fractures or malalignment of bony structures.There was soft tissue swelling overlying lateral and medial malleoius.No evidence of acute body trauma.On (b)(6) 2008, patient presented with complaint of tenderness in right ankle.X-ray showed no evidence of fracture or other abnormality.On (b)(6) 2008, (b)(6) 2009: the patient presented for an office visit reporting right ankle sprain.On (b)(6) 2008, (b)(6) 2009, patient presented with complaint of tenderness in right ankle.On (b)(6) 2011, patient presented for physical therapy and reported back pain.On (b)(6) 2011, patient presented for physical therapy and reported low back and left leg pain.On (b)(6) 2012: the patient was admitted with excessive or frequent menstruation.Final pathologic diagnosis: endometrium, biopsy; prol iferative endometrium.On (b)(6) 2014: the patient was diagnosed with abdominal pain, malaise and fatigue.On (b)(6) 2014: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent bilateral mammograms.Impression: area of increased density where the patient has a palpable abnormality.Category 4 classification, biopsy recommended.On (b)(6) 2014 the patient was presented for office visit with right breast mass.Assessment: birads 4 right breast mass in woman on chronic pain medication for lumbar spine problems.On (b)(6) 2014: the patient underwent open excisional right breast biopsy due to right breast mass.Findings: firm, multinodular breast tissue in the area of palpable concern; the total excised volume of breast tissue containing several small nodules was 3 cm x 4 cm x 2 cm.On (b)(6) 2014: the patient presented for an office visit and was diagnosed with cystic mastopathy.Final pathologic diagnosis: right breast, lesion of lateral aspect mastectomy with separate inferior and lateral margins, fibrocystic changes.Changes suggestive of pseudoangiomatous stromal hyperplasia.Negative for atypism, hyperplasia or malignancy.On (b)(6) 2015: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent diagnostic right mammogram for breast lump and limited right breast ultrasound.Impression: right breast nodule increased architectural distortion.Ultrasound guided biopsy is again recommended.Bi-rads category 4.On (b)(6) 2015: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent digital diagnostic mammogram of the right breast and core biopsy of the right breast.Conclusions: successful biopsy; successful placement of a marker clip.On (b)(6) 2015: the patient presented with host of problems like abnormal cardiovascular system function, chest pain, esophageal reflux, old myocardial infarction, unspecified essential hypertension, irritable bowel syndrome and encounter for long-term use of aspirin.The patient underwent the following procedures: left heart catheterization; selective left and right coronary angiography; left ventriculography (b)(6) 2015: the patient presented for an office visit for a second opinion and to establish cardiovascular care.Assessment: chest pain; palpitataions; esential hypertension; hyperlipidemia.
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Event Description
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It was reported that on (b)(6) 2000: the patient presented with chief complaint of hashimoto's and swollen throat nodes.On (b)(6) 2001: the patient presented for an office visit due to gestational hypertension and possible preeclampsia.On (b)(6) 2003 the patient underwent the following surgeries: laparoscopic gastric bypass to treat the following pre-op diagnosis: gastroesophageal reflux.Diabetes.Hypertension.Stress urinary incontinence.Degenerative joint disease of the knees.Back pain.Ankle and feet pain.Depression.Hypertriglyceridemia by history.Hypercholesterolemia by history.On (b)(6) 2003 patient presented for post op follow-up of gastric bypass upper gi.Impression: postoperative upper gi as described.On (b)(6) 2006: the patient presented for her annual exam and reported difficulty in swallowing.On (b)(6) 2006, (b)(6) 2008: the patient presented for an office visit due to abdominal pain and underwent egd procedure.Impression: the esophagus and gastroesophageal junction appeared normal.On (b)(6) 2007, (b)(6) 2008: the patient presented for a pap and annual examination.On (b)(6) 2007 the patient was presented for office visit with left cheek pain.Assessments: acute left maxillary sinusitis.On (b)(6) 2007 the patient was presented for office visit.Assessments: acute left maxillary sinusitis.On (b)(6) 2008: the patient presented for an office visit due to shingles on her face.On (b)(6) 2008: the patient presented for a follow up visit for herpes zoster on her face.On (b)(6) 2008: the patient presented for medications.On (b)(6) 2009 the patient was presented for office visit with headaches, fatigue and difficulty in sleeping.On (b)(6) 2009 patient underwent upper gi endoscopy.On (b)(6) 2009 patient underwent upper gi w small bowel.Impression: unobstructed flow of contrast through the different loop at the roux-en-y anaotomosis.However, there was a patulous afferent loop causing sever reflux into the hasaan.On (b)(6) 2010 patient presented for a postop follow-up.On (b)(6) 2010 patient underwent chest pa lateral.Impression: normal evaluation of the chest.On (b)(6) 2010: patient underwent x-ray.On (b)(6) 2010 patient presented for an office visit.On (b)(6) 2010 patient underwent dural probe 24 hour ph monitoring.On (b)(6) 2010 patient underwent stationary esophageal manometry.Impression: hypotensive lower esophageal sphincter.Normal peristalsis with 80% peristaltic contractions, 10% low amplitude peristaltic contractions, and 10% dropped contractions.Normal upper esophageal sphincter pressure and relaxation.On (b)(6) 2011 patient underwent pregnancy testing before anesthesia and surgery.On (b)(6) 2011 patient underwent laproscopic hernia repair to treat the following pre-op diagnosis: preoperative diagnosis(es): para esophageal hernia with herniated roux limb, status post roux-en-y gastric bypass.On (b)(6) 2011 patient presented for post op check.On (b)(6) 2011: patient presented for office visit.On (b)(6) 2011: the patient presented for an office visit and reportedly had continued pain, paresthesias and weakness.On (b)(6) 2011 the patient was presented for office visit with low grade fever and sinus infection.Assessments: acute left maxillary sinusitis.On (b)(6) 2011 patient underwent examination of chest.Impression: no acute or active disease process seen.On (b)(6) 2011: assessment: acute left maxillary sinusitis, neoplasm, uncertain, skin.On (b)(6) 2011: the patient presented for postoperative follow up.On (b)(6) 2011: the patient presented for a postoperative visit.On (b)(6) 2012 patient presented for office visit with consistent pain radiating to l buttock, posterior thigh, lateral leg and lateral aspect of the l foot.Impressions: the results of the electromyography and nerve conduction studies of the left lower extremity were felt to be consistent with the presence of an electro physiologically-moderate acute and chronic left si radiculopathy.The nerve conduction and electromyography studies of the right rower extremity were normal, there was no evidence of entrapment or other peripheral neuropathy, lumbosacral plexopathy, lumbar radiculopathy or myopathy.On (b)(6) 2012 patient presented for office visit with following procedure left s1 tfesi.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented for office visit with complaint of intense numbness that wraps around the left hip to groin and all the way down to left foot.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented for follow-up visit with complaint of chronic pain in the low back, as well as pain in the l hip, lateral thigh and leg and lateral foot.Impressions: consistent with the presence of an electro physiologically-moderate, primarily chronic, si radiculopathy.Changes classically associated with acute injury remain, which may be the case for quite some time (a year being not all that unusual) following an acute injury, with or without surgery.Again, no conclusive evidence of root injury, acute or chronic, could be demonstrated.Basically, there has been little interval change since (b)(6) of this year.The nerve conduction and electromyography studies of the right lower extremity were again normal; there was no evidence of entrapment or other peripheral neuropathy, lumbosacral plexopathy, lumbar radiculopathy or myopathy - on the right side.On (b)(6) 2012 patient underwent following procedure: bilateral si joint injection.On (b)(6) 2013 patient underwent following procedure: bilateral si joint injection.On (b)(6) 2013: the patient presented with following pre-op diagnosis: bilateral sacroiliac joint arthropathy.Lumbosacral pain.Left lower extremity radicular symptoms.Status post revision decompression and fusion l5-s1.The patient underwent: intravenous sedation.C-arm fluoroscopy.Bilateral si joint injection with steroid.On (b)(6) 2013 patient presented for office visit.On (b)(6) 2013: patient presented for followup, continuing with her pain management program in (b)(6).Patient's review of systems revealed: gastrointestinal: present- indigestion.Musculoskeletal: present- back pain, back stiffness and leg weakness.Neurological: present- balance problems.On (b)(6) 2013: patient presented with complaints of chronic lumbar radiculopathy.On (b)(6) 2013: patient was diagnosed pre-operatively with:.Bilateral sacroiliac joint arthropathy.Lumbosacral pain.Chronic left lower extremity radicular symptoms.Status post decompression/fusion with revision l5-s1.Patient underwent the following procedures: intravenous sedation.Fluoroscopy.Bilateral sacroiliac joint injections with steroid.On (b)(6) 2014: patient presented for evaluation and discussion of lle kafo.Patient stated that her knee had been giving out and buckling.On (b)(6) 2014: patient presented for office visit.On (b)(6) 2014 the patient was presented for office visit with back pain, pain in arms, legs and joints, constipation, nausea and difficulty in sleeping.On (b)(6) 2014: the patient underwent x-rays of the knee due to left knee pain and buckling.Impression: bad left knee with advanced changes in the retropatellar region and early to moderate changes of the lateral joint line.On (b)(6) 2015, the patient presented for office visit due to complaint of pain in joint , pelvic region , thigh.On (b)(6) 2015: patient presented with complaint for si joint pain.Patient had persistent left lower extremity pain and weakness.Impression: uncomplicated repeat bilateral sacroiliac joint injections.Planned lateral branch rhizotomy in the near future.On (b)(6) 2015: patient presented for office visit.Patient underwent ct of lumbar spine.Impression: anterior posterior surgical changes at l5-s1.Mild osteophytic changes arising posteriorly from the left aspect at the l5-s1 level may minimally contact and displace the traversing left s1 nerve root.There are spondylitic changes without significant spinal stenosis at any level.Mild left neural foraminal narrowing is seen at l3-4.On (b)(6) 2015: patient presented with chief complaint of left lower extremity pain.Patient underwent an intra-articular hip injection.On (b)(6) 2015: patient presented for follow up on left lower extremity symptoms, and on referral for a left l3-4 transforaminal epidural steroid injection.Patient was diagnosed pre-operatively with status post l5-s1 fusion, left lower extremity weakness, bilateral hip pain, chronic sacroilitis.Patient underwent fluoroscopic study and left l3-4 transforaminal epidural steroid injection.Impression: uncomplicated l3-4 transforaminal epidural steroid injection on the left.On (b)(6) 2015: patient got admitted with admitting diagnosis: lumbago and other musculooskeletal symptoms referable to limbs, pain in joint, pelvic region and thigh, sacroilitis.On (b)(6) 2015, (b)(6) 2016: patient underwent right hip therapeutic injection under fluoroscopic guidance.On (b)(6) 2015: patient visited for follow up on left lower extremity symptoms and complained of back pain.A 10 point review of systems completed and found to be otherwise negative.Assessment: left lower extremity weakness, right hip pain, bilateral sacro-iliac joint pain.On (b)(6) 2015: patient presented for an office visit and stated that she had left quad atrophy over the last year with weakness and pain in the posterior aspect of the leg as well.On (b)(6) 2015: the patient was administered steroid injection to the right hip under fluoroscopic guidance, due to right hip pain.On (b)(6) 2015: patient presented to er for wound repair.On (b)(6) 2015: patient presented with complaint of right knee pain.Assessment: osteoarthritis right knee, effusion right knee.Patient underwent x-ray of right knee (3 view).Impression: early osteoarthritic changes evidenced by some lateral joint space narrowing and spiking of the tibial spines.There is also a medial osteochondroma of the distal femur.On (b)(6) 2016 the patient was administered steroid injection to the right hip due to right hip pain that radiated into the groin and down the leg.On (b)(6) 2016: patient visited for follow up on right hip.
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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) 1998: patient presented with complaint of a poorly responding right index finger lesion suspected to be herpetic whitlow, and underwent physical examinations.Impression: herpetic whitlow, persistent pain; cbc, hepatic panel.On (b)(6) 2008, patient presented with complaints of right ankle pain on (b)(6) 2009 patient presented with complaints of cough, (b)(6) 2009 patient presented for an office visit.On (b)(6) 2010 : the patient presented with ruptured and fragmented disc on levels l5-s1.On (b)(6) 2011 the patient was presented for office visit with "uri".Assessments: sinusitis.
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Event Description
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On (b)(6) 2014: the patient presented for esophagogastroduodenoscopy.Impressions: normal esophagus.Anastomosis visualized near the stomach.Minimal pouch present, healthy anastamosis.Normal duodenum.The patient presented for colonoscopy.Impressions: mild diverticulosis found in the sigmoid colon.No large masses or lesions seen, colon was redundant, scope only passed to hepatic flexure.On (b)(6) 2014 patient presented for an office visit.On (b)(6) 2016: the patient presented for x-ray due to right hip pain.Impressions: osteoarthritic changes right hip.On (b)(6) 2013: the patient called doctor and decided to have si joint injection on (b)(6) 2013.Patient presented with complaints of trouble in breathing.On (b)(6) 2015: patient presented with complaint for si joint pain.Patient had persistent left lower extremity pain and weakness.Impression: uncomplicated repeat bilateral sacroiliac joint injections.Planned lateral branch rhizotomy in the near future.The patient underwent si joint injections.On (b)(6) 2015: patient got admitted with admitting diagnosis: lumbago and other musculoskeletal symptoms referable to limbs, pain in joint, pelvic region and thigh, sacroilitis.The patient had l3 injection on lt side (b)(6) 2015 patient presented due to the chief complaint of heart problems.The patient had si joint rf ablation on right side.Nine spots of each side were burned.On (b)(6) 2015 the patient had right hip and left si joint rf ablation injection.On (b)(6) 2016: the patient reported via social media that she had pain, ruptured<(>&<)> fragmented so the disc material <(>&<)> fragments oozed out the spinal canal.On (b)(6) 2016: the patient underwent cta coronary angiogram on an unknown date: the patient underwent x rays of her rt knee, aspirated about an ounce of serous fluid off of it , steroid injected and brace was fitted.
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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) 2011: the patient presented with left leg pain.Musculoskeletal examination revealed back pain, left leg pain and leg weakness.Neurological examination revealed balance problems and numbness in left hip and buttocks to foot.The patient was also depressed.
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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) 2011: examination of bilateral lower extremities demonstrates diffuse decrease sensation throughout essentially the entire left lower extremity.Diagnosis: well healed l5-s1 posterior instrumented fusion with some mild left lower extremity weakness of unclear etiology.
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Search Alerts/Recalls
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