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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Inflammation (1932); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Stenosis (2263); Anxiety (2328); Numbness (2415); Ambulation Difficulties (2544)
Event Date 02/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
Event Description
It was reported that on (b)(6) 2016: patient presented with internal disruption l5/s1 disk with intractable pain back and bilateral legs respectively, status post discographics workup.Patient underwent the following procedure, anterior lumbar interbody fusion at l5-s1 with radical discectomy using bone graft supercharged with rhbmp-2 with fluoroscopic supervision during same, and left intra-abdominal iliac vein repair.As per-op notes: ¿.I proceeded to graft the l5-s1 space with bone graft as a carrier supercharged with rhbmp-2.¿ on (b)(6) 2016: patient presented with left thigh and left calf compartment syndrome.On (b)(6) 2016: patient presented with left medial compartment(adductor) thigh compartment syndrome evolution with malfunctioning wound vac.Patient underwent left medial adductor thigh fasciotomy.Inspection and re-application of 2 wound vacs to the thigh and left(calf) wounds respectively.On (b)(6) 2016: patient presented with swelling on left foot.On (b)(6) 2016: patient presented for wound check 20.On (b)(6) 2016: patient presented with left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies, on (b)(6) 2016: patient presented in the office for repeat wound culture.On (b)(6) 2016: patient presented for two week wound check.On (b)(6) 2016: patient presented for wound check and post-op check.On (b)(6) 2016: patient presented with increased lumbar pain with x rays.On examination patient had sacral tenderness.Patient had cervicalgia, gerd and tenderness over the cervical thoracic junction.On (b)(6) 2016: patient underwent x-rays.On (b)(6) 2016: patient presented for a follow-up.Patient is reported ambulating without evidence of gait.On (b)(6) 2016: patient presented with pain.On (b)(6) 2016: patient presented with preoperative diagnosis of query left sacroiliitis and underwent left sacroiliac joint arthrogram with fluoroscopic guidance.On (b)(6) 2016: patient presented with significant back pain that radiated across her hip down her left lower extremity.Patient complained of significant anxiety.Review of her x-ray of her si joints are read as unremarkable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Patient demographics: initials: (b)(6).Gender: female.Age at the event: (b)(6), ethnicity: caucasian, patient clinical id: (b)(6).Pre-op diagnosis: lumbar stenosis procedure: anterior lumbar interbody fusion (alif) levels: l5-s1.It was reported that on (b)(6) 2016, intra-op, while surgeon was placing the trial, trial disengaged from the holder.The product came in contact with the patient.The patient had significant blood loss and perforated vein or vessel.Reportedly perforation required repair.Update received on 23 feb 2016: the perforation of what appeared to be the aorta was repaired to stop the massive blood loss.The doctor reported that the patient had to return to surgery twice over the weekend to repair a blood flow issue with her leg.The hospital had taken the trial and trial inserter used during the case and planned to keep it until an investigation could be completed.Updates received on 16-feb-2017: it was reported that on (b)(6) 2016, intra-op, the handle, which was used to place the template, dislodged from the template and hit the patient's iliac vein, resulting in a laceration of the iliac vein.The medtronic handle was used to place the medtronic template in the disc place, as a measuring device, prior to the insertion of the permanent medtronic cage.Allegedly, "as a result of the laceration to the iliac vein, the patient lost 4650 cc of blood before the neurosurgeon and a vascular surgeon in the operative suite were able to repair the iliac vein and stop the bleeding.Because of this event, the lt cage lumbar fusion was abandoned." reportedly, "following the laceration of the iliac vein, a valiant attempt was made to save the patient's life.A large volume of crystalloids, platelets, fresh frozen plasma (ffp), and other fluids were given to the patient.Once she was stabilized, she was transferred to the intensive care unit for follow-up care." allegedly, " an inspection of the medtronic template by the surgical technician in th e operative suite noted cross-threading between the template and the handle that led to assembly failure between the medtronic template and the medtronic handle." updates received on 20-feb-2017: it was reported to the sales rep that the trial and broach handle were being used when the injury occurred.Updates received on 01 mar 2017: medication: percocet, oxycodone, robaxin, diazepam, gabapentin, patient demographics: dob:(b)(6) 1969, patient initials:(b)(6).On (b)(6) 2016: patient presented with internal disruption l5/s1 disk with intractable pain back and bilateral legs respectively, status post discographics workup.Patient underwent the following procedure: anterior lumbar interbody fusion at l5-s1 with radical discectomy using mastergraft supercharged with infuse with fluoroscopic supervision during same, and left intraabdominal iliac vein repair.As per-op notes: ¿.I proceeded to graft the l5-s1 space with mastergraft as a carrier supercharged with infuse(bmp).¿ on (b)(6) 2016: patient presented with left thigh and left calf compartment syndrome.On (b)(6) 2016: patient presented with left medial compartment(adductor) thigh compartment syndrome evolution with malfunctioning wound vac.Patient underwent left medial adductor thigh fasciotomy.Inspection and re-application of 2 wound vacs to the thigh and left(calf) wounds respectively.On (b)(6) 2016: patient presented with swelling on left foot.On (b)(6) 2016: patient presented for wound check.On (b)(6) 2016: patient presented with left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies.On (b)(6) 2016: patient presented in the office for repeat wound culture.On (b)(6) 2016: patient presented for two week wound check.On (b)(6) 2016: patient presented for wound check and post-op check.On (b)(6) 2016: patient presented with increased lumbar pain with x rays.On examination patient had sacral tenderness.Patient had cervicalgia, gerd and tenderness over the cervical thoracic junction.On (b)(6) 2016: patient underwent x-rays.On (b)(6) 2016: patient presented for a follow-up.Patient is reported ambulating without evidence of gait.On (b)(6) 2016: patient presented with pain.On (b)(6) 2016: patient presented with preoperative diagnosis of query left sacroiliitis and underwent left sacroiliac joint arthrogram with fluoroscopic guidance.On (b)(6) 2016: patient presented with significant back pain that radiated across her hip down her left lower extremity.Patient complained of significant anxiety.Review of her x-ray of her si joints are read as unremarkable.Update received on on (b)(6) 2017: patient demographics- height: 5¿7¿¿, weight: (b)(6), bmi: (b)(6).Medical history: hypertension, migraine, fibromyalgia, back pain (lumbar), h/o: depression, anxiety state, dry eyes, arthritis.Surgical history: hysterectomy, c5-6 spinal fusion, cholecystectomy, appendectomy, left foot bone spur, tonsillectomy, tubal ligation, breast biopsy, skin tissue rearrangement, skin graft split thickness autograft.Allergies: ambien, amoxicillin, bee sting, latex, lexapro, morphine, no known food allergies social history: ex smoker, quit: 2008, never or rarely drinks alcohol, no current alcohol use family history: cancer (mother and sisters); diabetes, age at onset unspecified (mother and brothers); medication: hydromorphone, ondansetron, ativan (0.5 mg), celexa(40 mg), doxepin hcl, gabapentin, omeprazole, propranolol, restorilxxx, warfarin sodium.On (b)(6) 2016: the patient presented with left thigh and left calf open wounds status post fasciotomy with additional need for posterior tension band at l5-51.The patient underwent left thigh and calf wound debridement with preparation of recipient sites, extensive, with integra bilaminar skin graft substitute coverage medial and xxxateral left calf and left lateral thigh, with wound vacuum-assisted closure device negative pressure therapy application to same (even extended to posterior lumbar back) left medial thigh simple wound closure, posterior l5-s1 choice thunderbolt pedicle screw instrumentation of l5 through 51, with fluoroscopic supervision during procedure.Patient tolerated the procedure well.On (b)(6) 2016: the patient presented with pre-op diagnosis: left thigh and left calf compartment syndrome.The patient underwent monitoring of interstitial fluid pressure in detection of muscle compartment syndrome, followed by fasciotomy left thigh, and fasciotomies of left calf including anterior/lateral/deep posterior compartments, and application of a wound vacuum-assisted closure negative pressure therapy to same.Patient tolerated the procedure well.On (b)(6) 2016: the patient presented with pre-op diagnosis: left medial compartment (adductor) thigh compartment syndrome evolution with malfunctioning wound vac.The patient underwent, left medial adductor thigh fasciotomy.Inspection and re-application of 2 wound vacs to the thigh and leg (calf) wounds respectively.On (b)(6) 2016: the patient presented with pre-op diagnosis: left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies, anterior "tarsal" tunnel syndrome.The patient underwent debridement, preparation of recipient wound beds to left thigh and calf, followed by split thickness skin graft coverage for same, as well as trigger injection to anterior tarsal tunnel region in tibialis anterior/extensor hallucis longus zone.Patient tolerated the procedure well.On (b)(6) 2016: the patient presented for a follow-up post anterior lumbar interbody fusion l5-s1 ((b)(6) 2016).Patient reported that she had a previous intervention and developed a dvt of the left iliofemoral segment.Gunther ivc filter was placed on (b)(6) 2016 and is doing well.Bounding pulses.Musculoskeletal review of system: back pain, joint pain and joint swelling.Cardiovascular: leg cramps or pain in legs when walking a short distance.Patient was presented with other intervertebral disc degeneration, lumbosacral region.On (b)(6) 2016: the patient presented for a follow-up post anterior lumbar interbody fusion l5-s1 ((b)(6) 2016).Sites on her left leg have healed over well post wound vac therapy.Musculoskeletal review of system: back pain, joint pain and joint swelling.Cardiovascular: leg cramps or pain in legs when walking a short distance.Impression: ctv of pelvis for evaluation of vena cava.On (b)(6) 2016: the patient underwent ct of abdomen pelvis w/o contrast.Impression: the left common iliac vein, and external iliac vein are diminutive, and suspected occluded with collateral flow present.This may represent chronic changes from may xxxthurner syndrome, as on the prior ct in (b)(6) 2007, the left common iliac vein appears compressed by the right common iliac artery.On (b)(6) 2016, the patient with past h/o lumbar spine surgery presented with left lateral thigh cellulitis/abscess with swelling and redness with pain.Ct showed edema and inflammatory changes in muscle along with some gas.On (b)(6) 2016, as per medical records, assessment: lumbar degenerative disk disease with chronic pain.On (b)(6) 2016, the patient continued to have pain control issues.Swelling to left alter thigh seemed improved.Assessment: left lower extremity cellulitis.On (b)(6) 2016, the patient underwent ct.Xxxmpression: superficial adipose soft tissue edema and inflammation along the anterolateral aspect of the left mid thigh possibly representing cellulitis.No well-defined fluid collection is identified on this non-contrast exam.Small foci of air are present more posteriorly along the lateral aspect of the left thigh.In speaking with the referring clinician, the patient underwent needle aspiration of the left thigh today and this may represent sequela from that procedure.If this site does not correlate with the site of needle aspiration, gas forming infection could be considered as a potential cause.Post surgical changes from left lateral thigh fasciotomy with herniation of the lateral portion of the vastus lateralis muscle.On (b)(6) 2016, the patient presented with following pre-op diagnosis: deep venous thrombosis with contraindication to anticoagulation.The patient underwent right internal jugular approach vena cava filter evaluation with removal of vena cava filter.The patient tolerated the procedure well, was awakened and transported to the recovery room in stable condition.On (b)(6) 2016, the patient presented for a follow-up visit status post ivc filter removal ((b)(6) 2016).Musculoskeletal review of system: back pain, joint pain and joint swelling.Cardiovascular: leg cramps or pain in legs when walking a short distance.Patient was presented with other intervertebral disc degeneration, lumbosacral region.Impression: continue xxxwasfarin until after she is well healed from other interventions to her back and leg.Update received on 21 apr 2017: medication: amilriptylinexxx hcl, cyclobenzaprine hcl, dme, doxycycline ilyclatexxx, duloxetine hcl, epipen 2-pak, hydrocodone, lansoprazole, lorazepam, oxycodone, propranolol hcl, promethazine hcl, proairxxx hfa, rizatripatanxxx benzoate, warfarin sodium.Medical history: abdominal pain, acute sinusitis, contact dermatitis, nausea, furuncle, vomiting, urinary tract infection, viral gas troenteritisxxx, lumbar strain, otitis externa, stye surgical history: appendectomy, arthrodesis cervical to c5, cholecystectomy, hysterectomy, tonsillectomy, ostectomy calcaneus for sp ur family history: depression, malignant neoplasm of breast, ovarian cancer, breast cancer.Allergies: robaxin.On (b)(6) 2011: patient underwent mri cervical.Impression: degeneration and bulge to left at c5/6.On (b)(6) 2012: patient presented for follow-up visit with chief complaints of headaches and neck pain.Nervous system: migraines.On (b)(6) 2012: patient presented for follow-up visit with chief complaints of cervicalgia and headaches.Patient underwent the following procedures: cervical epidural steroid injection, c6/7, fluoroscopy and conscious intravenous sedation.On (b)(6) 2012: patient presented for follow-up visit.On (b)(6) 2012: patient underwent anterior cervical discectomy fusion surgery at c5/6.On (b)(6) 2012: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.On (b)(6) 2012: patient presented for follow-up to get medicines for anxiety, panic or depression.On (b)(6) 2012: patient presented for follow-up with chief complaints of ear and eye pain.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2012: patient presented for follow-up with chief complaints of ear and eye pain.Ros: constitutional: no fever and no chills.On (b)(6) 2012: patient presented for follow-up visit.On (b)(6) 2012: patient presented for follow-up with chief complaint of high blood sugar.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2012: patient presented for follow-up visit.On (b)(6) 2012: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2012: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2013: patient presented with following pre-op diagnosis: lumbago sciatica, low back pain.Patient underwent mri lumbar spine w/o contrast.Impression: small central disc protrusion l5-s1 with no significant spinal canal or neural foraminal stenosis present.On (b)(6) 2013: patient presented for follow-up visit.Ros: neurological: anxiety, migraines, chronic insomnia.On (b)(6) 2013: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2013: patient presented for follow-up visit with chief complaint of neck pain.07 may 2013: patient underwent mri cervical.Impression: moderate central stenosis at c5/6 with bilateral foraminal stenosis.Report showed fusion at c5/6 as well as some residual, moderate central stenosis with bilateral foraminal stenosis.On (b)(6) 2013: patient presented for follow-up visit with regard to her cervicalgia and headaches.Patient underwent the following procedures: translaminar epidural steroid injection, fluoroscopy.On (b)(6) 2013: patient presented for follow-up visit.On (b)(6) 2013: patient presented for follow-up of neck pain and headache.Ros: fatigue, anxiety, depression, headache, neck pain and fibromyalgia.On (b)(6) 2013: patient presented for follow-up with chief complaints of headache and sinus pain.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2013: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.On (b)(6) 2013: patient presented for follow-up with chief complaint of neck pain.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2013: patient presented for follow-up with chief complaints of nausea, diarrhea and abdominal pain.Ros: constitutional: fever and recent weight loss.On (b)(6) 2013: patient presented for follow-up visit.On (b)(6) 2013: patient presented for follow-up for an acute care evaluation.On (b)(6) 2014: patient presented for follow-up.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.Neurological: headache.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented for follow-up.Ros: musculoskeletal: neck pain, neurological: headache.On (b)(6) 2014: patient presented for follow-up with chief complaints of anxiety and abdominal pain.Ros: constitutional: no fever and no chills.On (b)(6) 2014: patient presented for follow-up with chief complaints of chest pain, high blood pressure and nausea.On (b)(6) 2014: patient presented for follow-up with chief complaint of sharp pain from right side to lower abdomen.Ros: constitutional: no fever and no chills.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented with following pre-op diagnosis: pain in limb.Patient underwent rad foot 3 view rt.Impression: no acute abnormality.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented for follow-up to discuss fibromyalgia, headache and diarrhea.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2014: patient presented for follow-up with chief complaints of headache and neck pain.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2014: patient presented for 1 month follow-up.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2014: patient presented for follow-up visit.On (b)(6) 2015: patient presented for follow-up visit.On (b)(6) 2015: patient presented for follow-up with chief complaints of cough and pruritus.Ros: constitutional: no fever and no chills.On (b)(6) 2015: patient presented for follow-up visit.13 feb 2015: patient presented for follow-up with chief complaints of depression, headache and pruritus.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2015: patient presented for follow-up visit.On (b)(6) 2015: patient presented for follow-up with chief complaints of anxiety and rashes.Ros: constitutional: feeling poor and tired.Musculoskeletal: arthralgias, joint pain, back and hip pain.On (b)(6) 2015: patient presented for follow-up visit.On (b)(6) 2015: patient presented for follow-up.Ros: constitutional: no fever and no chills.Neurological: headache.On (b)(6) 2015: patient presented for follow-up visit.On (b)(6) 2015: patient presented for follow-up with chief complaint of pain.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.Neurological: headache.On (b)(6) 2015: patient presented for follow-up visit.On (b)(6) 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented for follow-up with chief complaints of constipation, shortness of breath and tremor.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented for follow-up.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.01 apr 2016, 19 apr 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented for 1 month follow-up to discuss change of medicine as anxiety is getting worse.Patient has breast underarm pain on left side.Ros: constitutional: no fever and no chills.Neurological: headache.Musculoskeletal: patient was tender to superficial palpation in the left lateral upper chest region just under the axilla from the lat.Border of the scapula to the breast.On (b)(6) 2016: patient presented for follow-up.On (b)(6) 2016: patient presented for follow-up with chief complaint of cellulitis on left leg.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2016: patient presented for 1 month follow-up with chief complaint of headache.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.Neurological: headache.On (b)(6) 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented with chief complaint of chest pain.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2016: patient presented for follow-up visit.On (b)(6) 2016: patient presented for follow-up visit.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2017: patient presented for follow-up visit.On (b)(6) 2017: patient presented for post-op follow-up with chief complaint: anxiety and gets lost while going to places.Patient is not able to sleep well.Ros: constitutional: no fever and no chills.Musculoskeletal: back pain.On (b)(6) 2017: patient presented with chief complaint: cough.Ros: constitutional: fever and chills.Update received on 03 may 2017: medications: amitriptyline, cymbalta, flexeril, maxalt, phenergan, prevacid medical history/surgical history: lumbar radiculopathy , gastroesophageal reflux disease, mva with brief loc x 2, tonsillectomy, left heel surgery for spur , acdf, left leg vascular rupture during lumbar spine surgery, plif trauma/stress history: sexual abuse age 8 to 11, psychological and physical abuse; raped, daughter is bipolar and poor parent.Family psychiatric history: mother: bipolar disorder, schizophrenia and alcohol abuse, suicide; father: history of inpatient treatment; daughter: bipolar disorder.Brother: bipolar disorder, schizophrenia, alcohol and substance abuse.Substance history: tobacco: quit cigarettes nine years ago; alcohol: a rare alcoholic beverage, no history of abuse substance: tried marijuana for pain control per doctor¿s advice some years ago; caffeine: 1 coffee and 2 iced teas per day.Marital status: two times married.Educational history: quit second year of nursing school.Occupation/work status: ssdi former corrections officer, customer service representative, collection officer and group home counselor.On (b)(6) 2017: patient presented for schedule follow up.The patient referred for counselling associated with a trauma type response to a surgical equipment mishap last february.Diagnostic impressions: other specified trauma and stressor related disorder; r/o post-traumatic stress disorder.Panic disorder.Specific phobia (needled, heights, spiders, snakes).Chronic pain syndrome.On (b)(6) 2017: patient presented for follow up visit.On (b)(6) 2015: patient presented with low back pain, right leg pain and numbness.Update received on 04 may 2017: it was reported that on: (b)(6) 2015, the patient underwent ct of the lumbar spine done post discogram which showed that there is a grade 4 possible annular tear at l5-s1.On (b)(6) 2015, patient presented with complaint of back pain greater than her right lower extremity pain.The review of mri showed a dark disc at l5-s1 but the ct myelogram was generally unremarkable with only minimal disc herniation noted at l5-s1 level.On (b)(6) 2016, the patient was diagnosed with lumbar strain secondary to advanced disc degeneration chronic intractable with dynamic stenosis.On (b)(6) 2016, the patient presented with complaints of low back pain that radiates to her bilateral lower extremities with associated numbness, weakness and tingling.On (b)(6)2016, the patient went for an office an office visit due to new onset swelling on the left foot.On (b)(6) 2016, the patient presented for wound check.On (b)(6) 2016, the patient presented with anterior tarsal tunnel which was inflamed.On (b)(6) 2016, the patient presented with increased pain.The patient had (b)(4) sacral sulcus tenderness bilaterally indicative of adjacent level degeneration through sacroiliitis.On (b)(6) 2016, the patient went for an office visit requesting repeat for lumbar trigger injections.On (b)(6) 2016, the patient went for an office visit with a complaint of a red hot swollen area about the lateral aspect of her left thigh.On (b)(6) 2016, the patient presented for a follow-up.The patient was ambulating without evidence of gait antalgia.She was tender to palpation over the left sij sulcus.Imaging and ct showed not evidence of a fluid collection.On (b)(6) 2016, the patient continues to complain of significant back pain that radiated across her hips and down her left lower extremity.She also complained of a significant increase in her anxiety.Patient stated that the sij injection was essentially inadequate and non-durable providing her with essentially no relief.X-rays of patient¿s si joints appear that the left is somewhat arthritic appearing.On (b)(6) 2016, the patient presented with sacroiliac joint pain.On (b)(6) 2016, the patient presented for a visit post the sij arthrogram.On (b)(6) 2016, the patient presented with increased pain in the back and right leg.The patient recently had sij injection on the right side and the increased pain was secondary to inflammatory flare from the injection itself.On (b)(6) 2016, the patient underwent ct lumbar spine which showed early consolidation of graft and l5-s1 space.On (b)(6) 2017, the patient presented with increased pain.The patient describes the pain radiating down both legs.The patient underwent two sacroiliac joint injections.On (b)(6) 2017, the patient presented for a follow-up.On (b)(6) 2017, the patient presented for follow-up after sacroiliac joint injections.On (b)(6) 2017, the patient presented with chief complaint of ongoing lumbar pain.The patient complained about left foot swelling for approximately 2 days.The patient was minimally tender to palpation over her left lower extremity.Assessment: the patient does have noted osteoarthritis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on: (b)(6) 2015: the patient presented with back pain and bilateral lower extremity numbness.X-ray radiographs show slight loss of the lordotic curve.No anterior returolisthesis is noted.All disc heights are fairly well maintained without any significant degeneration noted.On (b)(6) 2015: the patient presented for pre-operative history and physical for a multi-level discogram.The patient states that she has back pain and leg pain.On (b)(6) 2015: the patient presented for follow up for lumbar discogram.The patient continues to have back pain that is greater than the leg pain.On (b)(6) 2015: the patient presented for a follow up after undergoing a payche evaluation.The patient states she continues to have back pain that is greater than her right lower extremity pain.On (b)(6) 2016: the patient presented post-op for examination.The x-rays of the lumbar spine looked good relative to the fusion mass within the interspace and the posterior screw absent evidence for complicating features.On (b)(6) 2016: the patient presented to evaluate new onset swelling in the left foot that developed last friday.On examination, the patient has no compartment syndrome.On (b)(6) 2016: the patient presented with complaints of low back pain that radiates to her bilateral lower extremities with associated numbness, weakness, and tingling.On (b)(6) 2016: the patient presented with anterior inflammation.This was a trigger for patient pain aggravation.On (b)(6) 2016: the patient reported increased pain, 10+.On examination, she had exquisite sacral sulcus tenderness bilaterally indicative of adjacent level degeneration through sacroilitis.On (b)(6) 2016: the patient presented with a complaint of red hot swollen area about the lateral aspect of her left thigh.On (b)(6) 2017: the patient continues to complaint of ongoing lumbar pain.On (b)(6) 2015: the patient presented with internal disc disruption with intractable lumbago and underwent lumbar discography.On (b)(6) 2016: the patient presented with internal disruption l5/s1 disc with intractable pain back and bilateral legs respectively, status post discographic workup.On (b)(6) 2016: the patient presented with left thigh and left calf compartment syndrome.On (b)(6) 2016: the patient presented with left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies.On (b)(6) 2016, (b)(6) 2017: the patient presented with right sacroilitis and underwent right sacroiliac joint arthrogram with fluoroscopic guidance.On (b)(6) 2018: the patient underwent mri l spine with/without contrast.Impression: extensive postop changes as above in the lower lumbar spine and si joints.No definite cause for the patient¿s symptoms is identified.Unknown date: the patient underwent radiographic recording.Impression: three months postoperative from a right si joint fusion, with excellent resolution of her back pain and radicular complaints on the right side.Left si joint dysfunction, previously treated with physical therapy and injections there, which have not been successful.She is therefore requesting a left si joint fusion.On (b)(6) 2018: the patient was pre-operatively diagnosed with left sacroiliitis and underwent left sacroiliac joint fusion using si-bone ifuse 3d triangular titanium implants x3.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6434958
MDR Text Key70859419
Report Number1030489-2017-00603
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,Followup,Followup
Report Date 08/29/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/01/2017
Initial Date FDA Received03/27/2017
Supplement Dates Manufacturer ReceivedNot provided
04/19/2017
08/02/2018
Supplement Dates FDA Received05/15/2017
10/02/2017
08/29/2018
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 Age47 YR
Patient Weight99
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