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)
Date of Event	07/14/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from consumer via a manufacturer representative regarding a patient having spinal therapy.It was reported that the patient experiencing chronic pain and requiring additional surgery due to ectopic bone growth following the implantation of medtronic infuse bone graft in the cervical spine during surgery performed on july 14, 2015.The patient was not notified of known risks, fda warnings, or legal actions related to the off-label use of infuse in the cervical region, and only recently became aware of these issues after ongoing health complications.There were no further complications reported regarding the event.Additional information was received that the infuse was used on (b)(6) 2014 at c5/6.The additional surgery to remove ectopic bone growth was (b)(6) 2015.Both surgeries were done at cedars sinai by eli baron.The decision to use infuse in neck was made by surgeon.
Additional Manufacturer Narrative
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.

• 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: 23357950
• Report Number: 3003120897-2025-00434
• Device Sequence Number: 12979637
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: (01)00613994239525(17)150331(10)M111306AAO
• Combination Product (Y/N): N
• PMA/510(K) Number: P000054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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
• Initial Report FDA Received Date: 10/22/2025
• 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