MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number TLIFIDE420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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 patient states he continues to have left lower extremity pain mostly in the thigh area.He claims the pain seems to have worsened on (b)(6) 2020.He describes pain as shooting, burning, hypersensitive to touch and throbbing.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: 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.Action subtype: physical therapy; action result: yes.Outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: other1; action result: no evidence of deep venous thrombosis; action date: (b)(6) 2020; action info: other diagnostic test: venous duplex 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 : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes.Comments: medtronic assessed as possibly related to the tlif grafting material.

Manufacturer Narrative

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.

Manufacturer Narrative

See b5 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.

Event Description

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 patient states he continues to have left lower extremity pain mostly in the thigh area.He claims the pain seems to have worsened on (b)(6) 2020.He describes pain as shooting, burning, hypersensitive to touch and throbbing.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: 2020-08-21 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: 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 action subtype: physical therapy; action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: other1; action result: no evidence of deep venous thrombosis; action date: (b)(6) 2020.Action info: other diagnostic test: venous duplex 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 : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes comments: medtronic assessed as possibly related to the tlif grafting material.Outcome status recovered/resolved; outcome date (b)(6) 2021.

Manufacturer Narrative

B5, b7 : 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.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.

Event Description

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 patient states he continues to have left lower extremity pain mostly in the thigh area.He claims the pain seems to have worsened on (b)(6) 2020.He describes pain as shooting, burning, hypersensitive to touch and throbbing.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: 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 action subtype: physical therapy; action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: other1; action result: no evidence of deep venous thrombosis; action date: (b)(6) 2020; action info: other diagnostic test: venous duplex 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 : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes comments: medtronic assessed as possibly related to the tlif grafting material.Outcome status recovered/resolved; outcome date (b)(6) 2021 upon exam there was left lateral malleolus swelling.

Event Description

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 patient states he continues to have left lower extremity pain mostly in the thigh area.He claims the pain seems to have worsened on (b)(6) 2020.He describes pain as shooting, burning, hypersensitive to touch and throbbing.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: 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 action subtype: physical therapy; action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: other1; action result: no evidence of deep venous thrombosis; action date: (b)(6) 2020; action info: other diagnostic test: venous duplex 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 : moderate.Site related assessment: this event was not related to any devices and causal relationship with surgical procedure used.Sponsor assessment: result: yes comments: medtronic assessed as possibly related to the tlif grafting material.Outcome status recovered/resolved; outcome date (b)(6) 2021 upon exam there was left lateral malleolus swelling.Along approximately the l5/s1 dermatome.

Manufacturer Narrative

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.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.

• 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
• MDR Report Key: 10578955
• MDR Text Key: 208300470
• Report Number: 1030489-2020-01337
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TLIFIDE420
• Device Catalogue Number: TLIFIDE420
• Device Lot Number: MAN2076AAX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR