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 08/21/2020

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), regarding a patient.The patient has medical history of hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminot ransferase, 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, deep vein thrombosis right lower extremity.The patient had had surgical and medical procedures of arthroscopic surgery of the right hip, dupuytren's contracture of the left hand and left elbow.Substance use : tobacco primary diagnosis: stenosis.Surgery date: (b)(6) 2020 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 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 surgical procedure-transforaminal lumbar interbody fusion.Sponsor assessment : result-yes.It was reported that the patient awoke from surgery with pain at the surgical site.This an expected occurrence post-surgery.Using the 0-10 pain scale, the pain was rated as a 10 at its worst.The severity is considered moderate and pain medication was administered.Intervention: drug therapy outcome: not recovered/not resolved.

Event Description

The information was received from a clinical study with clinical patient id: (b)(6), regarding a patient.The patient has medical history of hypertension, blurred vision, gastroesophageal reflux disease, heartburn, elevated alanine aminot ransferase, 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, deep vein thrombosis right lower extremity.The patient had had surgical and medical procedures of arthroscopic surgery of the right hip, dupuytren's contracture of the left hand and left elbow.Substance use : tobacco primary diagnosis: stenosis.Surgery date: (b)(6) 2020 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 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 surgical procedure-transforaminal lumbar interbody fusion.Sponsor assessment : result-yes.It was reported that the patient awoke from surgery with pain at the surgical site.This an expected occurrence post-surgery.Using the 0-10 pain scale, the pain was rated as a 10 at its worst.The severity is considered moderate and pain medication was administered.Intervention: drug therapy outcome: not recovered/not resolved.Updated information received on 2020-oct-29: 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.

Manufacturer Narrative

Additional information added in b5 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

Updated information received on (b)(6) 2021: sponsor assessment: fully adjudicated (b)(6)2021 as causal relationship to procedure.

Manufacturer Narrative

H1: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunction.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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

Mdr decision corrected to not reportable.No additional supplemental required unless additional information received indicates reportable event.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10558704
• MDR Text Key: 208099999
• Report Number: 1030489-2020-01312
• 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,Followup
• Report Date: 06/15/2023

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: TLIFIDE420
• Device Catalogue Number: TLIFIDE420
• Device Lot Number: MAN2076AAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 02/25/2021; 05/22/2023
• Supplement Dates FDA Received: 11/19/2020; 03/09/2021; 06/15/2023
• Date Device Manufactured: 11/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White