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	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
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
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient having spinal therapy.It was reported that, during a 12-month study follow-up assessment, the surgeon assessed fusion status at all treated spinal levels and noted that some fusion was seen but fusion had not fully occurred at all treated levels.No patient complications have been reported as a result of this event.Additional information was received that there was no confirmed device allegation, this was a reported clinical finding which may be considered normal for the clinical case.Safety has requested additional information that will be provided if the investigator determines an abnormal finding has occurred.

• 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: 25296528
• Report Number: 3003120897-2026-00938
• Device Sequence Number: 15765137
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: (01)00681490843805(17)250601(10)MHN3227AAL
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 7510400
• Device Catalogue Number: 7510400
• Device Lot Number: MHN3227AAL
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 04/23/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White