MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE® BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number TLIFIDE420

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

Patient Problem Ossification (1428)

Event Date 09/09/2022

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient with clinical id (b)(6) and study id (b)(6).It was reported that the patient completed a ct scan on (b)(6) 2022.The surgeon reviewed the same on (b)(6) 2022 and noticed left-sided ectopic bone growth which could potentially be impacting the patient's left leg pain.The patient's implants are intact and she appears to be solidly fused in the interbody space.The patient discussed potentially trying a transforaminal steroid injection at the l5-s1 segment with the surgeon.Diagnostics: mri without contrast on (b)(6) 2022 ; results- solidly fused in the interbody space; left- sided ectopic bone growth.Sponsor assessment: sponsor assessed not related to study procedure ; possibly related to tlif grafting material ; unlikely related to capstone peek spinal system and posterior supplemental fixation system.Medical history: gerd, arthritis, depression, bladder and urethra injury primary diagnosis: stenosis additional information received stated that: description- left-sided ectopic bone growth at l5-s1 outcome status- unknown narrative- ae involves level l5-s1 severity of ae- moderate site related assessment- unlikely related to capstone peek and tlif grafting material, not related to posterior supplemental fixation system, possibly related to study procedure (l5-s1 tlif) sponsor assessment- sponsor assessed as possibly related to study procedure ; possibly related to tlif grafting material ; unlikely related to capstone peek spinal system and posterior supplemental fixation system.Investigator assessment- possibly related to the tlif grafting material site related assessment- possibly related to tlif grafting material.The number of consecutive levels (from l2-s1) that will be treated: 1 most recent date the subject had either a ct or mri: (b)(6) 2021 medication history: subject has used non-narcotic medications, muscle relaxants, non-narcotic over the counter pain medications, and strong narcotic medications in the last 7 days date of hospital admission: 10-aug-21 date of hospital discharge: 16-aug-21 date of follow up visit: (b)(6) 2021, (b)(6) 2021, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 outcome status: not recovered/ not resolved additional surgical procedure date: (b)(6) 2023 details surgical procedure: left l5/s1 foraminotomy the additional surgical procedure involves l5-l6, l6-s1.Interventions: surgical treatment the additional surgical procedure involves l5-s1.Outcome status: recovering/ resolving additional surgery was performed.Site related assessment for additional surgery- unlikely related to capstone peek spinal system and posterior supplemental fixation system, probably related to tlif grafting material and study procedure (tlif with infuse) sponsor assessment for additional surgery- probably related to the tlif grafting material.No device deficiencies have been submitted in the tlif study.

Manufacturer Narrative

H3: 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.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

Update received: intervention: ae resulted in hospitalization from (b)(6) 2023 site seriousness assessment: medical intervention severity of ae: severe.

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

B5: updated event details additional annex f code updated due to medical intervention by injection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Intervention: patient was administered with a solution of 10mg dexamethasone pf 10mg/m and 4ml sodium chloride (pf) 0.9% was divided equally among the affected levels (l5-s1) and injected on (b)(6) 2023.After completion of the injection, the needle was flushed.

Event Description

Update received: site seriousness assessment: hospitalization (y) ; medical intervention (n) update received: sponsor assessment (cec): possibly related to procedure, tlif grafting material, interbody device.Not related to posterior supp.Fixation.Underwent left l5/s1 foraminotomy.

Manufacturer Narrative

B2: updated outcome attributed to adverse event- hospitalization b5: updated event details.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INFUSE® BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: 18052808
• MDR Text Key: 327125529
• Report Number: 1030489-2023-00728
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2024

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 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: 10/17/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 06/06/2024; 06/14/2024
• Supplement Dates FDA Received: 11/23/2023; 06/13/2024; 06/19/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White