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

Model Number	7510100
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Stenosis (2263); Numbness (2415)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from patient via a manufacturer representative who was implanted with infuse.The patient alleges development of ectopic bone growth post-implant requiring an additional surgery and reports ongoing chronic pain since the original implant.Posterior spinal fusion with infuse implant at c5/6 in (b)(6) 2014.Symptoms began in (b)(6) 2014 with severe neck/arm pain and numbness in the right hand/fingers; mri in (b)(6) 2014 confirmed foraminal stenosis not present on imaging prior to infuse implantation.A right cervical 5-6 transforaminal selective root block was performed on (b)(6) 2014 without success, followed by a foraminotomy on (b)(6) 2015 to address the new foraminal stenosis.Physician indicate an mri after a prior acdf showed no foraminal stenosis, and that stenosis developed in the interval after the (b)(6) 2014 posterior fusion; off-label use of infuse bone graft may be associated with ectopic bone growth leading to stenosis.The patient reported chronic neck/arm pain and numbness in the right thumb, pointer, and middle finger.
Additional Manufacturer Narrative
6a implanted date- month and year is valid for the implant date.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
2025 nov 7, update received, onset date, outcome, outcome date for the event of chronic pain in neck/arm.Onset date: 11/2014 outcome: repeat surgery outcome date: (b)(6) 2015, onset date, outcome, outcome date, severity for the events of numbness in right hand, numbness in right thumb, pointer and middle finger and foraminal stenosis.Onset date: 11/2014 outcome: repeat surgery outcome date: (b)(6) 2015.
Additional Manufacturer Narrative
B5.Desc evt problem updated 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
• 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: 23389043
• Report Number: 3003120897-2025-00451
• Device Sequence Number: 15997190
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: (01)00613994239525(17)150331(10)M111306AAO
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: 7510100
• Device Catalogue Number: 7510100
• Device Lot Number: M111306AAO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 06/13/2014
• 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
• Patient Sex: Unknown