MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Model Number	T42275
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Nerve Damage (1979); Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other - nerve damage.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 via a manufacturer representative from patient who was implanted with grafton.It was reported that patient was implanted with reported grafton during cervical spine surgery on (b)(6) 2020.During this surgery, the grafton bone graft product was implanted in patient's cervical spine.Patient alleged that using grafton in the cervical spine was a dangerous "off-label" use.Following the surgery and implantation of grafton, patient suffered severe and debilitating injuries, including but not limited to, uncontrolled ectopic bone growth, nerve damage, need for additional surgeries, daily debilitating nerve pain, decrease in mobility and movements of the neck.

• Brand Name: GRAFTON DBM
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• Manufacturer (Section G): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22977055
• Report Number: 3002600221-2025-00002
• Device Sequence Number: 15682972
• Product Code: NUN
• UDI-Device Identifier: 00643169123076
• UDI-Public: (01)00643169123076(17)230414
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 09/05/2025

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: 04/14/2023
• Device Model Number: T42275
• Device Catalogue Number: T42275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 04/14/2020
• 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; Other
• Patient Sex: Unknown