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	Nonunion/Delayed-union Bone Fracture (2369); Back pain (4895)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2.Pseudarthrosis.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)(4) study name ailliance.It was reported that patient 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.Ae term pseudarthrosis investigator assessment possible related to a medtronic cst device.Sponsor assessment casual relationship to a study procedure and possible related to a study device.
Additional Manufacturer Narrative
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
Action taken: medications: yes were any of these opiates or narcotics (adjusted or administered): yes hydrocodone/apap 10/325 ketamine methadone hydromorphone oxycodone hydrocodone- apap 7.5-325 mg tablet oxycodone- apap 10-325 mg tablet ketamine methadone fentanyl hydromorphone morphine er ae1 update: hospitalization details provided, assessed as sae by site and sponsor, add spine surg (1) reported did the ae result in the subject being hospitalized or a prolongation of an existing hospitalization - new hospitalization what is the start date of the hospitalization- (b)(6) 2025 what is the end date of the hospitalization- (b)(6) 2025 did the ae result in any treatment- yes; ae serious flag- yes date of additional spinal surgery- (b)(6) 2025 what was the primary reason for the additional spinal surgery- adverse event related to studyindex surgery if ae, specify the corresponding ae - 001_4 apr 2025_pseudarthrosis revision spinal levels: l5, s1.

• 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: 21863328
• Report Number: 1030489-2025-01762
• Device Sequence Number: 4592093
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/23/2025
• 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: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White