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 12/18/2020

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 clinical department regarding a patient with clinical study id - (b)(4) and patient id (b)(4) for a spinal therapy.It was reported that patient complained of bilateral hand and left upper extremity numbness hours postsurgery.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.Interventions action subtype: ae result in hospitalization action result: n 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 action subtype: physical therapy action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: x-ray1 action result: no acute osseous or articular abnormality action date: (b)(6) 2020 action type: diagnostic action subtype: x-ray2 action result: no definite acute abnormality of the cervical spine.Action date: 2020-12-20 action type: diagnostic action subtype: mri with contrast 3 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 action type: diagnostic action subtype: mri without contrast 4 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 action type: diagnostic action subtype: were any diagnostic test performed action result: y surgery date: (b)(6) 2020 spinal surgeon last name: matheus 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 ¿ moderate congenital anomaly n death n disability n hospitalization n 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-and stressor-related disorder, urinary retention, anterior cervical discectomy and fusion, tubal ligation, asthma, primary diagnosis: instability (b)(6) 2020, lsh-630690911, (rep) additional information received : sponsor assessment : result: yes comments: medtronic assessment to tlif grafting material is possible.

Event Description

The information was received from clinical department regarding a patient with clinical study id - (b)(4) and patient id ¿ (b)(6) for a spinal therapy.It was reported that patient complained of bilateral hand and left upper extremity numbness hours postsurgery.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.Interventions action subtype: ae result in hospitalization action result: n 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 action subtype: physical therapy action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: x-ray1 action result: no acute osseous or articular abnormality action date: 202 0-12-20 action type: diagnostic action subtype: x-ray2 action result: no definite acute abnormality of the cervical spine.Action date: (b)(6) 2020 action type: diagnostic action subtype: mri with contrast3 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 action type: diagnostic action subtype: mri without contrast4 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 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 ¿ moderate congenital anomaly n death n disability n hospitalization n 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 : sponsor assessment : result: yes comments: medtronic assessment to tlif grafting material is possible.Additional information received : no infection noted additional information received : narrative: patient complained of bilateral hand and left upper extremity numbness hours postsurgery and tingling to bilateral hands.

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.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 complained of bilateral hand and left upper extremity numbness hours postsurgery.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.Interventions action subtype: ae result in hospitalization action result: n 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 action subtype: physical therapy action result: yes outcome status not recovered/not resolved diagnostics action type: diagnostic action subtype: x-ray1 action result: no acute osseous or articular abnormality action date: (b)(6) 2020 action type: diagnostic action subtype: x-ray2 action result: no definite acute abnormality of the cervical spine.Action date: (b)(6) 2020 action type: diagnostic action subtype: mri with contrast3 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 action type: diagnostic action subtype: mri without contrast4 action result: superficial fluid collections which are likely seromas action date: (b)(6) 2020 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 ¿ moderate congenital anomaly n death n disability n hospitalization n 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-and stressor-related disorder, urinary retention, anterior cervical discectomy and fusion, tubal ligation, asthma, primary diagnosis: instability (b)(6) 2021, lsh-630690911, (rep) additional information received : sponsor assessment : result: yes comments: medtronic assessment to tlif grafting material is possible.(b)(6) 2021, lsh-630690911, (rep) additional information received : no infection noted (b)(6) 2021, lsh-630690911, (rep) additional information received : narrative: patient complained of bilateral hand and left upper extremity numbness hours postsurgery and tingling to bilateral hands.(b)(6) 2021, lsh-630690911, (rep) additional information received : sponsor assessment (oc muo): cec assessed poss related to procedure; not related to tlif graft, interbody device or posterior fixation.

Manufacturer Narrative

Section b5: 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.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 11184405
• MDR Text Key: 233590524
• Report Number: 1030489-2021-00082
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Date Device Manufactured: 09/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian