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

Model Number TLIFIDE210

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

Patient Problem Pain (1994)

Event Date 01/09/2021

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 clinical department regarding a patient with clinical study id - (b)(6) for a spinal therapy.It was reported that patient presented to the ed with chronic lower back pain and new radicular symptoms.She also complained of neck pain with radiation into her left trapezius.She stated it started on saturday when she experienced a "twitching" with movement.She states that the pain was a 9 out of 10 in severity.She reports her low back pain radiating into her right lower extremity with some tingling sensations.She also states that she feels as though her lumbar hardware is "moving" and has started experiencing shooting pains and radicular symptoms through her bilateral lower extremities.She was admitted into the hospital from the er for pain management, thus the event is considered severe.Interventions - action subtype: ae result in hospitalization action result: y action date: (b)(6)2021.If subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n.Action subtype: emergency room visit action result: yes action date:(b)(6) 2021 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.Outcome status not recovered/not resolved diagnostics - action type: diagnostic action subtype: ct without contrast1 action result:(b)(6) action date: (b)(6) 2021.Action type: diagnostic action subtype: mri without contrast2 action result: (b)(6) action date: (b)(6)2021.Action type: diagnostic action subtype: were any diagnostic test performed action result: y 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: right soak time for the rhbmp-2 onto the acs prior to implantation.Superior treated level: 39 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: 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 related assessment: not related to any parts and have causal relationship with procedure.Site seriousness assessment: severity of ae, severe congenital anomaly: n, death: n, disability: n, hospitalization: y, life threatening: n, medical intervention: n, medical history: microcytic anemia, mrsa colonization, cervical disc disease, cervical radiculopathy, facet degeneration of lumbar region.Grade 1 anterolisthesis, l5/s1 spondylolisthesis, lower back pain, lumbar disc herniation, lumbar radicular syndrome, osteoarthritis, scoliosis, migraines, neurology, paresthesias, neurology, conversion disorder, unspecified trauma-andstressor-related disorder, urinary retention, anterior cervical discectomy and fusion, tubal ligation, asthma, primary diagnosis: instability.2021-jan-13, lsh- 630690912, (rep): additional information received states that: intervention: end date of the hospitalization: (b)(6) 2021.Sponsor assessment: result: yes, (b)(6) 2021,email_1, (rep): additional information received states that : drug therapy post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours and physical therapy.The current outcome is not recovered/not resolved.The current outcome of somatic symptom disorder and worsening of radicular pain is not recovered/not resolved.(b)(6) 2020 mri lumbar spine with and without contrast: impression: posterior fusion of l5-s1.Hardware artifacts iimit evaluation of adjacent structures.Peripheral enhancing fluid within the left greater than right subcutaneous tissues superficial to the fusion hardware.Could represent seroma or hematoma, though superimposed infection not excluded and correlation recommended with clinical symptoms.Additional peripheral enhancing focus of t2 to hypointense signal seen within the paraspinal muscles.This is nonspecific, could represent postoperative fluid collection including hematoma, though infection not excluded.(b)(6) 2021 ct lumbar spine without contrast: impression: limited exam due to extensive beam hardening artifact from the posterior fusion hardware.L5-s1 endplate irregularity and intervertebral density, possibly reflecting expected postsurgical changes.No significant paravertebral or paraspinal soft tissue edema.(b)(6) 2021 mri lumbar spine without contrast: impression: posterior fusion construct and intervertebral disc hardware at l5-s1.Marrow edema at the l5 and s1 endplates adjacent to disc hardware which is new since december.Suspected granulation tissue causing moderate left neural foraminal stenosis at l5-s1.Patient complained of bilateral hand and left upper extremity numbness hours post-surgery.Postoperatively patient is experiencing radiation of pain into the left gluteal region.She also has decreased sensation to the lower left extremity.She also complains of neck, left shoulder and back pain.X-rays show no sign of early complications.Post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours.Mri of lumbar spine taken on (b)(6) 2020 shows superficial fluid collections which are likely seromas.No infection noted.

Manufacturer Narrative

B5: updated with additional information.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 clinical department regarding a patient with clinical study id - (b)(6) and patient id ¿ (b)(6) for a spinal therapy.It was reported that patient presented to the ed with chronic lower back pain and new radicular symptoms.She also complained of neck pain with radiation into her left trapezius.She stated it started on saturday when she experienced a "twitching" with movement.She states that the pain was a 9 out of 10 in severity.She reports her low back pain radiating into her right lower extremity with some tingling sensations.She also states that she feels as though her lumbar hardware is "moving" and has started experiencing shooting pains and radicular symptoms through her bilateral lower extremities.She was admitted into the hospital from the er for pain management, thus the event is considered severe.Interventions - action subtype: ae result in hospitalization.Action result: y.Action date: (b)(6) 2021 if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n.Action subtype: emergency room visit action result: yes.Action date: (b)(6) 2021.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.Outcome status not recovered/not resolved diagnostics - action type: diagnostic action subtype: ct without contrast 1 action result: negative action date: (b)(6) 2021 action type: diagnostic action subtype: mri without contrast 2 action result: negative action date: (b)(6) 2021 action type: diagnostic action subtype: were any diagnostic test performed action result: y 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: right soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 39 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: 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 related assessment: not related to any parts and have causal relationship with procedure.Site seriousness assessment: severity of ae ¿ severe congenital anomaly n death n disability n hospitalization y life threatening n medical intervention n medical history: microcytic anemia, mrsa colonization, cervical disc disease, cervical radiculopathy, facet degeneration of lumbar region, grade 1 anterolisthesis, l5/s1 spondylolisthesis, lower back pain, lumbar disc herniation, lumbar radicular syndrome, osteoarthritis, scoliosis, migraines, neurology, paresthesias, neurology, conversion disorder, unspecified trauma-andstressor-related disorder, urinary retention, anterior cervical discectomy and fusion, tubal ligation, asthma, primary diagnosis: instability.Additional information received states that: intervention: end date of the hospitalization: (b)(6) 2021 sponsor assessment: result: yes.Additional information received states that : drug therapy post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours and physical therapy.The current outcome is not recovered/not resolved.The current outcome of somatic symptom disorder and worsening of radicular pain is not recovered/not resolved.(b)(6) 2020 mri lumbar spine with and without contrast: impression: 1.Posterior fusion of l5-s1.Hardware artifacts limit evaluation of adjacent structures.2.Peripheral enhancing fluid within the left greater than right subcutaneous tissues superficial to the fusion hardware.Could represent seroma or hematoma, though superimposed infection not excluded and correlation recommended with clinical symptoms.3.Additional peripheral enhancing focus of t2 to hypointense signal seen within the paraspinal muscles.This is nonspecific, could represent postoperative fluid collection including hematoma, though infection not excluded.(b)(6) 2021 ct lumbar spine without contrast: impression: limited exam due to extensive beam hardening artifact from the posterior fusion hardware.L5-s1 endplate irregularity and intervertebral density, possibly reflecting expected postsurgical changes.No significant paravertebral or paraspinal soft tissue edema.(b)(6) 2021 mri lumbar spine without contrast: impression: 1.Posterior fusion construct and intervertebral disc hardware at l5-s1.Marrow edema at the l5 and s1 endplates adjacent to disc hardware which is new since december.2.Suspected granulation tissue causing moderate left neural foraminal stenosis at l5-s1.Patient complained of bilateral hand and left upper extremity numbness hours post-surgery.Postoperatively patient is experiencing radiation of pain into the left gluteal region.She also has decreased sensation to the lower left extremity.She also complains of neck, left shoulder and back pain.X-rays show no sign of early complications.Post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours.Mri of lumbar spine taken on (b)(6) 2020 shows superficial fluid collections which are likely seromas.No infection noted.Additional information received states that : action result: marrow edema at the l5 and s1 endplates action date: (b)(6) 2021.

Event Description

The information was received from clinical department regarding a patient with clinical study id - (b)(6) and patient id ¿ (b)(6) for a spinal therapy.It was reported that patient presented to the ed with chronic lower back pain and new radicular symptoms.She also complained of neck pain with radiation into her left trapezius.She stated it started on saturday when she experienced a "twitching" with movement.She states that the pain was a 9 out of 10 in severity.She reports her low back pain radiating into her right lower extremity with some tingling sensations.She also states that she feels as though her lumbar hardware is "moving" and has started experiencing shooting pains and radicular symptoms through her bilateral lower extremities.She was admitted into the hospital from the er for pain management, thus the event is considered severe.Interventions - action subtype: ae result in hospitalization action result: y action date: (b)(6) 2021 if subject hospitalized, is it a prolongation (>24 hours) of an existing hospitalization: n action subtype: emergency room visit action result: yes action date: (b)(6) 2021 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.Outcome status not recovered/not resolved diagnostics - action type: diagnostic action subtype: ct without contrast1 action result: negative action date: (b)(6) 2021 action type: diagnostic action subtype: mri without contrast2 action result: negative action date: (b)(6) 2011 action type: diagnostic action subtype: were any diagnostic test performed action result: y 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: right soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 39 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: 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 related assessment: not related to any parts and have causal relationship with procedure.Site seriousness assessment: severity of ae ¿ severe congenital anomaly n death n disability n hospitalization y life threatening n medical intervention n medical history: microcytic anemia, mrsa colonization, cervical disc disease, cervical radiculopathy, facet degeneration of lumbar region, grade 1 anterolisthesis, l5/s1 spondylolisthesis, lower back pain, lumbar disc herniation, lumbar radicular syndrome, osteoarthritis, scoliosis, migraines, neurology, paresthesias, neurology, conversion disorder, unspecified trauma-andstressor-related disorder, urinary retention, anterior cervical discectomy and fusion, tubal ligation, asthma, primary diagnosis: instability.Additional information received states that: intervention: end date of the hospitalization: (b)(6) 2021 sponsor assessment: result: yes additional information received states that : drug therapy post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours and physical therapy.The current outcome is not recovered/not resolved.The current outcome of somatic symptom disorder and worsening of radicular pain is not recovered/not resolved.(b)(6) 2020 mri lumbar spine with and without contrast: impression: 1.Posterior fusion of l5-s1.Hardware artifacts iimit evaluation of adjacent structures.2.Peripheral enhancing fluid within the left greater than right subcutaneous tissues superficial to the fusion hardware.Could represent seroma or hematoma, though superimposed infection not excluded and correlation recommended with clinical symptoms.3.Additional peripheral enhancing focus of t2 to hypointense signal seen within the paraspinal muscles.This is nonspecific, could represent postoperative fluid collection including hematoma, though infection not excluded.(b)(6) 2021 ct lumbar spine without contrast: impression: limited exam due to extensive beam hardening artifact from the posterior fusion hardware.L5-s1 endplate irregularity and intervertebral density, possibly reflecting expected postsurgical changes.No significant paravertebral or paraspinal soft tissue edema.(b)(6) 2021 mri lumbar spine without contrast: impression: 1.Posterior fusion construct and intervertebral disc hardware at l5-s1.Marrow edema at the l5 and s1 endplates adjacent to disc hardware which is new since december.2.Suspected granulation tissue causing moderate left neural foraminal stenosis at l5-s1.Patient complained of bilateral hand and left upper extremity numbness hours post-surgery.Postoperatively patient is experiencing radiation of pain into the left gluteal region.She also has decreased sensation to the lower left extremity.She also complains of neck, left shoulder and back pain.X-rays show no sign of early complications.Post-op day #4 she reported complete loss of sensation in the lower left extremity and started on decadron for 24 hours.Mri of lumbar spine taken on (b)(6) 2020 shows superficial fluid collections which are likely seromas.No infection noted.Additional information received states that : action result: marrow edema at the l5 and s1 endplates action date: (b)(6) 2021 additional information received states that : action result: l5-s1 endplate marrow edema & suspect granulation tissue causing mod left neural foraminal stenosis.

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.

• 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: 11291299
• MDR Text Key: 242883810
• Report Number: 1030489-2021-00152
• 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
• Report Date: 04/06/2021

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
• Device Expiration Date: 08/31/2021
• Device Model Number: TLIFIDE210
• Device Catalogue Number: TLIFIDE210
• Device Lot Number: M30041863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 03/23/2021; 04/02/2021
• Supplement Dates FDA Received: 03/24/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 104