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

Model Number	2991226
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient awoke from surgery with pain in her lower back/surgical site.She describes the pain as feeling of tightness in the lower back area.This an expected occurrence post-surgery.Using the 0-10 pain scale, the pain was rated as an 8.Levels involved: l4-l5, surgery date: on (b)(6) 2020, surgical access: minimally invasive (i.E.Metrx or quadrant).Side of capstone insertion - superior treated level: right.Soak time for the rhbmp-2 onto the acs prior to implantation - superior treated level: 30 minutes volume of local bone autograft implanted ¿ superior treated level: 1 cc volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level: 8 cc total estimated blood loss: 20 ml.The subjects interbody space preparation and graft placement completed as instructed per the surgical checklist.Site seriousness assessment: this event was not related to any congenital anomaly, death, disability, hospitalization, life threaten ing, medical intervention, and severity of ae is moderate.Site relatedness assessment: the event is not related to any of the devices used but casual relationship with study procedure-transforaminal lumbar interbody fusion.Surgical history: discectomy, start date: on (b)(6) 2020, spinal level: l4-l5.Primary diagnosis: recurrent disc herniation.Interventions: action subtype: ae resulted in hospitalization and drug therapy.Outcome status was not recovered/not resolved.Updated information received on 01-dec-2020: outcome status: recovered/resolved.Outcome date: on (b)(6) 2020.2025-feb-10, email: additional information received: seriousness criteria - this is a serious or sae.In-patient or prolonged hospitalization.Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.Site relatedness assessment: causal relationship to procedure (tlif) and intervertebral body fusion device, unlikely related to tlif grafting material, not related to posterior supplemental fixation system.Sponsor assessment: causal relationship to procedure (transforaminal lumbar interbody fusion) and intervertebral body fusion device, not related to tlif grafting material, not related to posterior supplemental fixation system.Cec assessment: causal relationship to procedure and interbody device, not related to tlif grafting material and posterior supplemental fixation system.Cec rationale for surgical construct and procedure relationship adjudication - inner body device migrated confirmed by postopper imaging causally related to the adverse event.
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 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: 21544488
• Report Number: 1030489-2025-01236
• Device Sequence Number: 7857807
• Product Code: MAX
• UDI-Device Identifier: 00613994290953
• UDI-Public: 00613994290953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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 Model Number: 2991226
• Device Catalogue Number: 2991226
• Device Lot Number: H5584321
• 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: 02/10/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2020
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American