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MEDTRONIC SOFAMOR DANEK USA, INC; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Model Number TLIFIDE420 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Wound Dehiscence (1154)
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| Event Date 09/05/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The following products have been used in the surgery: part# tlifide420; lot# man2076aax; pma# p000058; udi# (b)(4), qty#1.Part# 55850016545; lot# h5545852 ; 510k# k170679; udi# (b)(4) qty# 3.Part# 55850016550; lot# h5544144; 510k# k170679; udi# (b)(4) qty# 1.Part# 6540530; lot# h5553497; 510k# k170679; udi# (b)(4) qty# 4.Part# 2991026; lot# h5289541; 510k# k073291; udi# (b)(4).Qty# 1 part# msb_unk_rod; lot# 0597294w; 510k# n/a; udi# n/a., qty# 2.Part# msb_unk_tissue; sl# (b)(4); 510k# n/a; udi# n/a, qty# 1.Part# msb_unk_tissue; sl# (b)(4); 510k# n/a; udi# n/a qty# 1.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that on (b)(6) 2020 steri strips fell off and patient noted drainage from the incisional site.He was admitted for wound infection washout on (b)(6) 2020.He has a pinpoint sized dehiscence of his surgical incision with a scant amount of serous drainage.No surrounding cellulitis or clear evidence of infection were noted.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date: (b)(6) 2020.Spinal surgeon last name: cress treatment levels name: l5-s1 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: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 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: 10 cc total estimated blood loss: 50 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 interventions : action subtype: ae result in hospitalization; action result: y; action date: (b)(6) 2020 ; if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy action result: yes outcome status not recovered/not resolved diagnostics action type: action type: diagnostic; action subtype: blood test1; action result: normal; action date: (b)(6) 2020.Action type: diagnostic; action subtype: clinical observation2; action result: afebrile; action date: (b)(6) 2020.Action type: diagnostic; action subtype: neurological exam3; action result: normal; action date: (b)(6) 2020.Action type: diagnostic; action subtype: x-ray4; action result: no acute abnormality; action date: (b)(6) 2020.Action type: diagnostic; action subtype: mri with contrast5; action result: possible peripheral enhancing fluid surrounds the leftsided hardware at l5; action date: (b)(6) 2020.Action type: diagnostic; action subtype: mri without contrast6; action result: peripheral enhancing fluid at the laminectomy site; action date: (b)(6) 2020.Action type: diagnostic; action subtype: were any diagnostic test performed; action result: y site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : severe.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Additional information received states that on (b)(6) 2020 patient was taken to the operating room for an elective incision and debridement of lumbar wound.The left paramedian incision was opened and areas of dehiscence and less healthy tissue were excised.No obvious findings consistent with infection.The field was copiously irrigated.Interventions: action subtype: surgical treatment;action result: yes additional surgery site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Adverse event info: does the adverse event involve a lumbosacral spinal level: n add surgical proc date - 01: (b)(6) 2020.Details surgical proc - 01: elective incision and debridement of lumbar wound is the additional surgical procedure an elective removal - 01: n does the additional surgical procedure involve a spinal level - 01: n does the additional surgical procedure involve an explant related to the study procedure - 01: n sponsor assessment (oc muo): result: yes comments: (b)(6) 2020 mri with contrast: possible peripheral enhancing fluid surrounds the left-sided hardware at l5.Intervention: end date of the hospitalization: (b)(6) 2020 sponsor assessment (oc muo): result: yes comments: site responded to query and stated that possible peripheral enhancing fluid surrounds the left-sided hardware at l5 from (b)(6) 2020 mri with contrast is not an ae.Outcome status: recovered/resolved outcome date: (b)(6) 2020.
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Event Description
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The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that on (b)(6) 2020 steri strips fell off and patient noted drainage from the incisional site.He was admitted for wound infection washout on (b)(6) 2020.He has a pinpoint sized dehiscence of his surgical incision with a scant amount of serous drainage.No surrounding cellulitis or clear evidence of infection were noted.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date: (b)(6) 2020, spinal surgeon last name: (b)(6), name: l5-s1 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: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 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: 10 cc total estimated blood loss: 50 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 interventions : action subtype: ae result in hospitalization; action result: y; action date: (b)(6) 2020 ; if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy action result: yes outcome status not recovered/not resolved diagnostics action type: action type: diagnostic; action subtype: blood test1; action result: normal; action date: (b)(6) 2020, action type: diagnostic; action subtype: clinical observation2; action result: afebrile; action date: (b)(6) 2020, action type: diagnostic; action subtype: neurological exam3; action result: normal; action date: (b)(6) 2020, action type: diagnostic; action subtype: x-ray4; action result: no acute abnormality; action date: (b)(6) 2020, action type: diagnostic; action subtype: mri with contrast5; action result: possible peripheral enhancing fluid surrounds the leftsided hardware at l5; action date: (b)(6) 2020, action type: diagnostic; action subtype: mri without contrast6; action result: peripheral enhancing fluid at the laminectomy site; action date: (b)(6) 2020, action type: diagnostic; action subtype: were any diagnostic test performed; action result: y site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : severe.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Additional information received states that on (b)(6) 2020 patient was taken to the operating room for an elective incision and debridement of lumbar wound.The left paramedian incision was opened and areas of dehiscence and less healthy tissue were excised.No obvious findings consistent with infection.The field was copiously irrigated.Interventions: action subtype: surgical treatment;action result: yes, additional surgery site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Adverse event info: does the adverse event involve a lumbosacral spinal level: n add surgical proc date - 01: (b)(6) 2020 details surgical proc - 01: elective incision and debridement of lumbar wound is the additional surgical procedure an elective removal - 01: n does the additional surgical procedure involve a spinal level - 01: n does the additional surgical procedure involve an explant related to the study procedure - 01: n sponsor assessment (oc muo): result: yes, comments: (b)(6) 2020 mri with contrast: possible peripheral enhancing fluid surrounds the left-sided hardware at l5.Intervention: end date of the hospitalization: (b)(6) 2020 sponsor assessment (oc muo): result: yes comments: site responded to query and stated that possible peripheral enhancing fluid surrounds the left-sided hardware at l5 from (b)(6) 2020 mri with contrast is not an ae.Outcome status: recovered/resolved outcome date: (b)(6) 2020 updated information received on 16 - oct -2020: email_1, (sdy,rep): for tlif ide study, a medication case report form is completed at the preop/baseline, surgery/hospital, discharge, 6 weeks, 3 months, 6 months, 12 months, and 24 months <(>&<)> annually.The medication case report form asks about nonsteroidal anti-inflammatory drugs since the last study visit, corticosteroids since last study visit, anti-coagulants since the last study visit, bisphosphonates since the last study visit, chemotherapy since the last study visit; and the investigator simply marks yes or no.It also asks about non-narcotic over-the-counter usage, weak narcotic medications, strong narcotic medications and any muscle relaxant.During the surgery visit, it was reported that: the subject used unspecified non-narcotic prescription: often (nearly every day, 6 to 7 days a week) the subject used unspecified muscle relaxants in the often (nearly every day, 6 to 7 days a week) during the 6 week visit, it was reported that: has the subject used any nonsteroidal anti-inflammatory drugs since the last study visit: yes has the subject had any corticosteroids since the last study visit: yes has the subject had any anti-coagulants since the last study visit: yes has subject used any non-narcotic prescription medications in the last 7 days (e.G., celebrex or gabapentinoids (neurontin or lyrica)): often (nearly every day, 6 to 7 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): often (nearly every day, 6 to 7 days a week) has subject used any muscle relaxants in the last 7 days (e.G., flexeril, parafon forte, or robaxin): often (nearly every day, 6 to 7 days a week) for subject # (b)(6): weight is 98 kg and height is 175.3 cm.The reported ae term was updated to incisional dehiscence as no obvious findings consistent with infection.No aes assessed by the investigator as infuse related.Additional information received states that all cultures came back negative.No sign of infection.Outcome date (b)(6) 2020.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that on (b)(6) 2020 steri strips fell off and patient noted drainage from the incisional site.He was admitted for wound infection washout on (b)(6) 2020.He has a pinpoint sized dehiscence of his surgical incision with a scant amount of serous drainage.No surrounding cellulitis or clear evidence of infection were noted.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date:(b)(6) 2020.Spinal surgeon last name: (b)(6).Treatment levels name: l5-s1.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: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 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: 10 cc total estimated blood loss: 50 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 interventions : action subtype: ae result in hospitalization; action result: y; action date: (b)(6) 2020 ; if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: any other action(s) taken action result: n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy action result: yes outcome status not recovered/not resolved diagnostics action type: action type: diagnostic; action subtype: blood test1; action result: normal; action date: (b)(6) 2020 action type: diagnostic; action subtype: clinical observation2; action result: afebrile; action date:(b)(6) 2020 action type: diagnostic; action subtype: neurological exam3; action result: normal; action date: (b)(6) 2020 action type: diagnostic; action subtype: x-ray4; action result: no acute abnormality; action date: (b)(6) 2020 action type: diagnostic; action subtype: mri with contrast5; action result: possible peripheral enhancing fluid surrounds the leftsided hardware at l5; action date: (b)(6) 2020 action type: diagnostic; action subtype: mri without contrast6; action result: peripheral enhancing fluid at the laminectomy site; action date: (b)(6) 2020 action type: diagnostic; action subtype: were any diagnostic test performed; action result: y site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : severe.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Additional information received states that on (b)(6) 2020 patient was taken to the operating room for an elective incision and debridement of lumbar wound.The left paramedian incision was opened and areas of dehiscence and less healthy tissue were excised.No obvious findings consistent with infection.The field was copiously irrigated.Interventions: action subtype: surgical treatment;action result: yes.Additional surgery site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Adverse event info: does the adverse event involve a lumbosacral spinal level: n add surgical proc date - 01: (b)(6) 2020 details surgical proc - 01: elective incision and debridement of lumbar wound is the additional surgical procedure an elective removal - 01: n does the additional surgical procedure involve a spinal level - 01: n does the additional surgical procedure involve an explant related to the study procedure - 01: n sponsor assessment (oc muo): result: yes comments: (b)(6) 2020 mri with contrast: possible peripheral enhancing fluid surrounds the left-sided hardware at l5.Intervention: end date of the hospitalization: (b)(6) 2020 sponsor assessment (oc muo): result: yes.Comments: site responded to query and stated that possible peripheral enhancing fluid surrounds the left-sided hardware at l5 from (b)(6) 2020 mri with contrast is not an ae.Outcome status: recovered/resolved outcome date: (b)(6) 2020 for tlif ide study, a medication case report form is completed at the preop/baseline, surgery/hospital discharge, 6 weeks, 3 months, 6 months, 12 months, and 24 months <(>&<)> annually.The medication case report form asks about nonsteroidal anti-inflammatory drugs since the last study visit, corticosteroids since last study visit, anti-coagulants since the last study visit, bisphosphonates since the last study visit, chemotherapy since the last study visit; and the investigator simply marks yes or no.It also asks about non-narcotic over-the-counter usage, weak narcotic medications, strong narcotic medications and any muscle relaxant.During the surgery visit, it was reported that: the subject used unspecified non-narcotic prescription: often (nearly every day, 6 to 7 days a week) the subject used unspecified muscle relaxants in the often (nearly every day, 6 to 7 days a week) during the 6 week visit, it was reported that: has the subject used any nonsteroidal anti-inflammatory drugs since the last study visit: yes has the subject had any corticosteroids since the last study visit: yes has the subject had any anti-coagulants since the last study visit: yes has subject used any non-narcotic prescription medications in the last 7 days (e.G., celebrex or gabapentinoids (neurontin or lyrica)): often (nearly every day, 6 to 7 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): often (nearly every day, 6 to 7 days a week) has subject used any muscle relaxants in the last 7 days (e.G., flexeril, parafon forte, or robaxin): often (nearly every day, 6 to 7 days a week) for subject # (b)(6) : weight is 98 kg and height is 175.3 cm.The reported ae term was updated to incisional dehiscence as no obvious findings consistent with infection.No aes assessed by the investigator as infuse related.Additional information received states that all cultures came back negative.No sign of infection.Outcome date (b)(6) 2020 for subject # (b)(6) : constipation: outcome: recovered/resolved stop date: (b)(6) 2020 ((b)(6) 2020) any treatment: drug therapy (names or categories of drugs not specified) left lateral malleolus swelling: outcome: recovered/resolved stop date: (b)(6) 2020 ((b)(6) 2020) any treatment: the site reported that this ae did not result in any treatment.The additional information was received from a clinical study with clinical patient id: (b)(6) , sponsor assessment (oc muo) final adjudication is causal relationship.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Manufacturer Narrative
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B5 & b7: additional information updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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The information was received from a clinical study with clinical patient id: (b)(6), via a manufacturing representative regarding a patient for spinal therapy.It was reported that on (b)(6) 2020 steri strips fell off and patient noted drainage from the incisional site.He was admitted for wound infection washout on (b)(6) 2020.He has a pinpoint sized dehiscence of his surgical incision with a scant amount of serous drainage.No surrounding cellulitis or clear evidence of infection were noted.Medical history: hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminotransferase, elevated aspartate aminotransferase, anterolisthesis of l5-s1, bilateral neuroforaminal stenosis, broad based disc herniation at the lumbar 5 sacral 1, central canal stenosis, central disc herniation at lumbar 4 5, discogenic disease at l5-s1, impingement of the spinal canal, isolated discogenic disease at l-5s1, left buttock pain, left lower extremity radiculopathy, lower back pain, weakness of plantar flexion of the left foot, change in stream, stones, testicular pain, arthroscopic surgery of the right hip, dupuytren's contracture of the left hand, left elbow, deep vein thrombosis right lower extremity, primary diagnosis: stenosis.Additional surgery : surgery date: (b)(6) 2020, spinal surgeon last name: (b)(6), treatment levels name: l5-s1, 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: left soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 33 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: 10 cc total estimated blood loss: 50 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 interventions : action subtype: ae result in hospitalization; action result: y; action date: (b)(6) 2020; if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n, action subtype: any other action(s) taken action result: n, action subtype: did the ae result in any treatment action result: y, action subtype: drug, therapy action result: yes, outcome status not recovered/not resolved, action type: diagnostic; action subtype: blood test1; action result: normal; action date: (b)(6) 2020, action type: diagnostic; action subtype: clinical observation2; action result: afebrile; action date: (b)(6) 2020, action type: diagnostic; action subtype: neurological exam3; action result: normal; action date: (b)(6) 2020, action type: diagnostic; action subtype: x-ray4; action result: no acute abnormality; action date: (b)(6) 2020, action type: diagnostic; action subtype: mri with contrast5; action result: possible peripheral enhancing fluid surrounds the leftsided hardware at l5; action date: (b)(6) 2020, action type: diagnostic; action subtype: mri without contrast6; action result: peripheral enhancing fluid at the laminectomy site; action date: (b)(6) 2020, action type: diagnostic; action subtype: were any diagnostic test performed; action result: y site seriousness assessment: congenital anomaly, death, disability, hospitalization, life threatening.Medical intervention are not present.Severity of ae : severe.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Additional information received states that on (b)(6) 2020 patient was taken to the operating room for an elective incision and debridement of lumbar wound.The left paramedian incision was opened and areas of dehiscence and less healthy tissue were excised.No obvious findings consistent with infection.The field was copiously irrigated.Interventions: action subtype: surgical treatment;action result: yes additional surgery site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Adverse event info: does the adverse event involve a lumbosacral spinal level: n add surgical proc date - 01: (b)(6) 2020, details surgical proc - 01: elective incision and debridement of lumbar wound is the additional surgical procedure an elective removal - 01: n does the additional surgical procedure involve a spinal level - 01: n does the additional surgical procedure involve an explant related to the study procedure - 01: n sponsor assessment (oc muo): result: yes comments: (b)(6) 2020 mri with contrast: possible peripheral enhancing fluid surrounds the left-sided hardware at l5.Intervention: end date of the hospitalization: (b)(6) 2020 sponsor assessment (oc muo): result: yes comments: site responded to query and stated that possible peripheral enhancing fluid surrounds the left-sided hardware at l5 from (b)(6) 2020 mri with contrast is not an ae.Outcome status: recovered/resolved outcome date: (b)(6) 2020 for tlif ide study, a medication case report form is completed at the preop/baseline, surgery/hospital discharge, 6 weeks, 3 months, 6 months, 12 months, and 24 months & annually.The medication case report form asks about nonsteroidal anti-inflammatory drugs since the last study visit, corticosteroids since last study visit, anti-coagulants since the last study visit, bisphosphonates since the last study visit, chemotherapy since the last study visit; and the investigator simply marks yes or no.It also asks about non-narcotic over-the-counter usage, weak narcotic medications, strong narcotic medications and any muscle relaxant.During the surgery visit, it was reported that: the subject used unspecified non-narcotic prescription: often (nearly every day, 6 to 7 days a week) the subject used unspecified muscle relaxants in the often (nearly every day, 6 to 7 days a week) during the 6 week visit, it was reported that: has the subject used any nonsteroidal anti-inflammatory drugs since the last study visit: yes has the subject had any corticosteroids since the last study visit: yes has the subject had any anti-coagulants since the last study visit: yes has subject used any non-narcotic prescription medications in the last 7 days (e.G., celebrex or gabapentinoids (neurontin or lyrica)): often (nearly every day, 6 to 7 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): often (nearly every day, 6 to 7 days a week) has subject used any muscle relaxants in the last 7 days (e.G., flexeril, parafon forte, or robaxin): often (nearly every day, 6 to 7 days a week) for subject # (b)(6): weight is 98 kg and height is 175.3 cm.The reported ae term was updated to incisional dehiscence as no obvious findings consistent with infection.No aes assessed by the investigator as infuse related.Additional information received states that all cultures came back negative.No sign of infection.Outcome date (b)(6) 2020 for subject # (b)(6): constipation: outcome: recovered/resolved stop date: (b)(6) 2020 ((b)(6) 2020) any treatment: drug therapy (names or categories of drugs not specified) left lateral malleolus swelling: outcome: recovered/resolved stop date: (b)(6) 2020 ((b)(6) 2020) any treatment: the site reported that this ae did not result in any treatment.The additional information was received from a clinical study with clinical patient id: (b)(6), sponsor assessment (oc muo) final adjudication is causal relationship.The additional information was received from a clinical study with clinical patient id: (b)(6), diagnostics: action subtype: biopsy7 action result: negative action date: (b)(6) 2020.
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