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

Model Number MSB_UNK_BMP2_ACS

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

Patient Problem Pain (1994)

Event Date 11/11/2020

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

Information was received from a clinical study regarding a patient with clinical patient id: (b)(6).It was reported that on (b)(6) 2020 patient complained of intermittent sciatic pain.Surgery date: (b)(6) 2020 treatment levels name: l4-l5 was the procedure navigated: y was a mazor robot used during the procedure: n surgical access: minimally invasive (i.E.Metrx or quadrant) side of capstone insertion - superior treated level: right soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 30 minutes volume of local bone autograft implanted - superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 8 cc total estimated blood loss: 20 ml was an intra-wound antibiotic (iwa) used: n was the subjects interbody space preparation and graft placement completed as instructed per the surgical checklist: y site seriousness assessment: this event was not related to any congenital anomaly, death, disability, hospitalization, life threatening, medical intervention, and severity of ae is moderate.Site relatedness assessment: the event is not related to any of the devices used but casual relationship with study procedure-transforaminal lumbar interbody fus ion.Medical history: diabetes mellitus type 2, bilateral hip arthritis, bilateral hip pain, bilateral hip degenerative joint disease, chronic lumbar radiculopathy, diffuse spondylosis, disc herniation at l4/5, grade 1 anterolisthesis, lower back pain, trochanteric bursitis, retinal reattachment, right shoulder open subacromial decompression and rotator cuff repair.Surgical history: discectomy, start date: (b)(6) 2020, spinal level: l4-l5 primary diagnosis: recurrent disc herniation interventions: action subtype: ae result in hospitalization :n action subtype: any other action(s) taken : n action subtype: did the ae result in any treatment action result: y action subtype: drug therapy : yes were any diagnostic test performed action result: n outcome status not recovered/not resolved updated information received on 16-nov-2020: sponsor assessment: result: yes comments: medtronic assessed as possible for related to the tlif grafting material.Updated information received on (b)(6)2020: outcome status: recovered/resolved outcome date: (b)(6) 2020.

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.

Event Description

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

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.

Event Description

Updated information received on 15-jan-2021: action(s) taken included drug therapy (the study site did not provide details) the outcome was reported as recovered/resolved with ae end date of (b)(6) 2020.

• 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: 10934209
• MDR Text Key: 219374770
• Report Number: 1030489-2020-01731
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR