Information was received from a clinical study regarding a patient with clinical patient id: (b)(6).It was reported that on (b)(6) 2020 patient complained of intermittent sciatic pain.Surgery date: (b)(6) 2020 treatment levels name: l4-l5 was the procedure navigated: y was a mazor robot used during the procedure: n surgical access: minimally invasive (i.E.Metrx or quadrant) side of capstone insertion - superior treated level: right soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 30 minutes volume of local bone autograft implanted - superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 8 cc total estimated blood loss: 20 ml was an intra-wound antibiotic (iwa) used: n was the subjects interbody space preparation and graft placement completed as instructed per the surgical checklist: y site seriousness assessment: this event was not related to any congenital anomaly, death, disability, hospitalization, life threatening, medical intervention, and severity of ae is moderate.Site relatedness assessment: the event is not related to any of the devices used but casual relationship with study procedure-transforaminal lumbar interbody fus ion.Medical history: diabetes mellitus type 2, bilateral hip arthritis, bilateral hip pain, bilateral hip degenerative joint disease, chronic lumbar radiculopathy, diffuse spondylosis, disc herniation at l4/5, grade 1 anterolisthesis, lower back pain, trochanteric bursitis, retinal reattachment, right shoulder open subacromial decompression and rotator cuff repair.Surgical history: discectomy, start date: (b)(6) 2020, spinal level: l4-l5 primary diagnosis: recurrent disc herniation interventions: action subtype: ae result in hospitalization :n action subtype: any other action(s) taken : n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy : yes were any diagnostic test performed action result: n outcome status not recovered/not resolved updated information received on 16-nov-2020: sponsor assessment: result: yes comments: medtronic assessed as possible for related to the tlif grafting material.Updated information received on (b)(6)2020: outcome status: recovered/resolved outcome date: (b)(6) 2020.
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Information was received from a clinical study regarding a patient with clinical patient id: (b)(6) it was reported that on (b)(6) 2020 patient complained of intermittent sciatic pain.Surgery date: 2020-11-09 treatment levels name: l4-l5 was the procedure navigated: y was a mazor robot used during the procedure: n surgical access: minimally invasive (i.E.Metrx or quadrant) side of capstone insertion - superior treated level: right soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 30 minutes volume of local bone autograft implanted - superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 8 cc total estimated blood loss: 20 ml was an intra-wound antibiotic (iwa) used: n was the subjects interbody space preparation and graft placement completed as instructed per the surgical checklist: y site seriousness assessment: this event was not related to any congenital anomaly, death, disability, hospitalization, life threatening, medical intervention, and severity of ae is moderate.Site relatedness assessment: the event is not related to any of the devices used but casual relationship with study procedure-transforaminal lumbar interbody fus ion.Medical history: diabetes mellitus type 2, bilateral hip arthristis, bilateral hip pain, bilaterl hip degenerative joint disease, chronic lumbar radiculopathy, diffuse spondylosis, disc hernation at l4/5, grade 1 anterolistesis, lower back pain, trochanteric bursitis, retinal reattachment, right shoulder open subacromial decompression and rotator cuff repair.Surgical history: discectomy, start date: (b)(6) 2020, spinal level: l4-l5 primary diagnosis: recurrent disc herniation interventions: action subtype: ae result in hospitalization :n action subtype: any other action(s) taken : n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy : yes were any diagnostic test performed action result: n outcome status not recovered/not resolved updated information received on 16-nov-2020: sponsor assessment: result: yes comments: medtronic assessed as possible for related to the tlif grafting material.Updated information received on 01-dec-2020: outcome status: recovered/resolved outcome date: 2020-11-18 updated information received on 03-dec-2020: onset date: 2020-11-11 updated information received on 08-dec-2020: "patient¿s height: 154.9 cm lot number of infuse: the site entered ¿n/a¿ for the lot number concomitant medication: name, dose, route, duration of treatment, date of last dose.[specific concomitant medications usage are collected at various study visits.Below are the baseline and surgery visit for subject # 015485004.] medications (baseline) has the subject used any nonsteroidal anti-inflammatory drugs within 30 days of the scheduled study surgical procedure: no has the subject had any corticosteroids within 30 days of the scheduled study surgical procedure: no has the subject had any chemotherapy within 30 days of the scheduled study surgical procedure: no has the subject had any anti-coagulants within 30 days of the scheduled study surgical procedure: no has the subject had any bisphosphonates within 30 days of the scheduled study surgical procedure: no has the subject undergone administration of any other types of anti-neoplastic, immunostimulating, or immunosuppressive agents, or m edications known to interfere with the healing of bone or soft tissue within 30 days of the scheduled study surgical procedure: no has subject used non-narcotic over the counter pain medications in the last 7 days (e.G., ibuprofen (motrin, advil), naproxen (aleve), aspirin, or acetaminophen (tylenol)): not at all has subject used any non-narcotic prescription medications in the last 7 days (e.G., celebrex or gabapentinoids (neurontin or lyrica)): not at all has subject used any weak narcotic medications in the last 7 days (e.G., tylenol 3, darvocet, darvon, vicodin, lorcet, or norco): sometimes (3 to 5 days a week) has subject used strong narcotic medications in the last 7 days (e.G., percocet, percodan, dilaudid, duragesic, actiq, oxycontin, demerol, or kadian): not at all has subject used any muscle relaxants in the last 7 days (e.G., flexeril, parafon forte, or robaxin): sometimes (3 to 5 days a week) any treatment taken for the events, sciatic pain [drug therapy (unspecified)] and pain at the surgical site [drug therapy (unspecifi ed)] lab details, if any.[no labs reported.] medication assessment as on 09-nov-2020: has the subject used any nonsteroidal anti-inflammatory drugs since the last study visit : no has the subject had any corticosteroids since the last study visit : no has the subject had any anti-coagulants since the last study visit : no has the subject had any bisphosphonates since the last study visit: no has the subject had any chemotherapy since the last study visit: no has subject used non-narcotic over the counter pain medications in the last 7 days (e.G.,ibuprofen (motrin, advil),naproxen (aleve), aspirin, or acetaminophen (tylenol)): not at all has subject used any non-narcotic prescription medications in the last 7 days (e.G., celebrex or gabapentinoids (neurontin or lyrica)) : not at all has subject used any weak narcotic medications in the last 7 days (e.G., tylenol 3, darvocet, darvon, vicodin, loree!, or norco) : not at all has subject used strong narcotic medications in the llast 7 days (e.G., percocet, percodan, dilaudid, duragesic, actiq, oxycontin, demerol, or kadian) : not at all has subject used any muscle relaxants in the last 7 days (e.G., flexeril, parafon forte, or robaxin) : not at all ".
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