MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE® SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	2991026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient with clinical id (b)(4) and study id (b)(6).It was reported that the patient experienced right lumbar radiculopathy.Patient developed right-sided radiating pain secondary to severe right foraminal stenosis at l5/s1 and degenerative tilt at l5/s1 to the right.Mri- facet arthropathy, ligamentum thickening, moderate central canal stenosis, severe right and moderately severe left foraminal narrowing at l5/s1.Moderate right foraminal stenosis at l4/l5.Patient underwent removal of hardware at l3/l5 with tlif at l2/l3 and l5/s1.Posterior fusion l2/s1 on (b)(6) 2023.The number of consecutive levels (from l2-s1) that will be treated: 3 impact: referral to psychiatrist for surgical treatment.L5/s1 esi ordered additional medical intervention required to prevent permanent injury or impairment: patient had in-patient or prolonged hospitalization.Patient underwent medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function investigator assessment: related to a study procedure (tlif l3/l5), probably related to the tlif grafting material, probably related to the intervertebral body fusion device, probably related to the posterior supplemental fixation system sponsor assessment: unlikely related to procedure, possibly related to tlif grafting material, possibly related to the intervertebral body fusion device, possibly related to posterior supplemental fixation system primary diagnosis: stenosis.
Event or Problem Description
The event is duplicate and hence it is being updated to non-reportable.
Additional Manufacturer Narrative
H2.Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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: CAPSTONE® SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 18109694
• Report Number: 1030489-2023-00747
• Device Sequence Number: 5428728
• Product Code: MAX
• UDI-Device Identifier: 00613994290991
• UDI-Public: 00613994290991
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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 Model Number: 2991026
• Device Catalogue Number: 2991026
• Device Lot Number: H5541094
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 04/07/2025
• Date Device Manufactured: 06/26/2019
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White