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

Model Number	7510400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Back pain (4895)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mdr was submitted in accordance with activities related to capa#734075 h6: 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 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 or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient with clinical id (b)(6) and study id (b)(6) stail device used for posterior fixation fusion procedure.It was reported that patient had pseudarthrosis.Interventions: action subtype: hospitilization action result: new hospitilization action date: (b)(6) 2025 action subtype: ae result in any treatment \action result: yes action subtype: medication administration action result: yes any of these opiates or narcotics (adjusted or administred) yes action subtype: spinal surgery action result: yes specify the additional spinal surgery additional spinal surgery, (b)(6) 2025 medication_name: fentanyl start_date: (b)(6) 2025 dose: 25 dose uom: ug frequency: prn: as needed route: intravenous reason started/indication: pain end_date: (b)(6) 2025 corresponding ae 001_(b)(6) 2025_pseudarthrosis medication_name: hydromorphone start_date: (b)(6) 2025 dose: 0.5 dose uom: mg frequency: prn: as needed route: intravenous reason started/indication: pain end_date: (b)(6) 2025 corresponding ae 001_(b)(6) 2025_pseudarthrosis medication_name: morphine er start_date: (b)(6) 2025 dose: 15 doseuom: mg frequency: prn: as needed route: oral reason started/indication: pain corresponding ae 001_(b)(6) 2025_pseudarthrosis medication_name: oxycodone start_date: (b)(6) 2025 dose: 10 dose uom: mg frequency: prn: as needed route: oral reason started/indication: pain end_date: (b)(6) 2025 corresponding ae 001_(b)(6) 2025_pseudarthrosis medication_name: oxycodone-apap 10-325 mg tablet start_date: (b)(6) 2025 dose: 1 dose uom: tablet frequency: prn: as needed route: oral reason started/indication: pain end_date: (b)(6) 2025 corresponding ae 001_(b)(6) 2025_pseudarthrosis outcome status:not recovered/resolved adverse event info: date the site became aware of event (b)(6) 2025 relative time from the procedure post surgery date of additional surgery (b)(6) 2025 primary reason for the additional surgery adverse event related to study index surgery specify the corresponding ae 001_(b)(6) 2025_pseudarthrosis type of additional surgery: revision yes spinal levels l5 : yes spinal levels s1 : yes mdt cst ailliance eligible devices implanted during the idx surg, remain in the subject at the end of this add spinal surgery y subevent number: 001 narrative: complaining of persistent back pain with radiculopathy.Imaging showed l5-s1 has a crack through his fusion at l5-s1 with fluids in the disc space.No signs of infection.Site seriousness assessment: congenital anomaly: no death: no disability: no hospitalization: yes, life threatening: no medical or surgical intervention: yes, site related assessment: adverse event related to the procedure and related to the device.

• Brand Name: INFUSE BONE GRAFT
• Common Device Name: 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24672316
• Report Number: 3003120897-2026-00568
• Device Sequence Number: 10331503
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: (01)00681490843805(17)260201(10)MHH4683AAC
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: 7510400
• Device Catalogue Number: 7510400
• Device Lot Number: MHH4683AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White