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 Codes	Muscle Weakness/Atrophy (1967); Pain (1994)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implant date unknown.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient with clinical id: (b)(6) and clinical study id: (b)(6) having transforaminal lumbar interbody fusion (tlif) l3/l5 therapy.It was reported that patient complained of right hamstring and buttock pain, right extensor hallucis longus weakness l4/5.Ct scan on (b)(6) 2022 confirmed a right foraminal stenosis l5/s1 and adjacent level degeneration (b)(6) 2023: tlif l2/l3 and l5/s1 with posterior instrumentation at l2/s1 was performed.Primary diagnosis: stenosis interventions:   action subtype: ae result in hospitalization action result: n  action subtype: any other action(s) taken action result: y other action taken: mri ordered action subtype: did the ae result in any treatment, action result: y action subtype: drug therapy, action result: yes action subtype: surgical treatment, action result: yes outcome status: recovered/ resolved outcome date: (b)(6) 2024 diagnostics:  action type: diagnostic action subtype: ct without contrast1 action result: l5/s1 foraminal stenosis action date: (b)(6) 2022  action type: diagnostic action subtype: were any diagnostic test performed action result: y action type: diagnostic, action subtype: mri without contrast2, action result: severe right and moderately severe left foraminal stenosis l5/s1 action date: (b)(6) 2023.Adverse event info: does the adverse event involve a lumbosacral spinal level: y if yes, levels involved: l5-s1  site seriousness assessment: severity of ae- severe, medical intervention- y.Site-related assessment: possible relationship with  l3/l5 tlif procedure.Not related to capstone peek spinal system implant, posterior supplemental fixation system and tlif grafting material.Sponsor assessment (oc muo): possible related to study procedure.Add surgical proc date - 03: (b)(6) 2023 details surg proc - 03: tlif l2/l3 and l5/s1, posterior instrumentation removal at l3/l5 with posterolateral arthrodesis, segmental instrumentation at l2/s1.Is the additional surgical procedure an elective removal - 03: y, adjacent levels tlif and segmental instrumentation if yes, were the index treated level(s) fused prior to the elective removal of the fixation component of the original surgical construct - 03: y does the additional surgical procedure involve a spinal level - 03: y add.Surg: if yes, levels involved - 03: l2-l3, l3-l4, l4-l5, l5-s1 does the additional surgical procedure involve an explant related to the study procedure - 03: y cause of explantation - 03: adjacent level decompression and fusion findings for explantation - 03: severe stenosis at l2/l3 and l5/s1 due to degenerative tilt of l3, l4, l5 into the sacrum on the right findings at add.Surg - 03: solid evidence of fusion at l3/l5 biopsies taken - 03: n site related assessment for additional surgery: probable relationship with l3/l5 tlif procedure.Possible relationship with capstone peek spinal system implant and posterior supplemental fixation system.Not related to tlif grafting material.There were no further complications reported regarding the event.

• 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: 20566085
• Report Number: 1030489-2024-01399
• Device Sequence Number: 7817323
• Product Code: MAX
• UDI-Device Identifier: 00613994290991
• UDI-Public: 00613994290991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 10/30/2024

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 Expiration Date: 08/26/2024
• Device Model Number: 2991026
• Device Catalogue Number: 2991026
• Device Lot Number: H5301060
• 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: 10/03/2024
• Initial Report FDA Received Date: 10/30/2024
• Date Device Manufactured: 08/26/2016
• 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 Ethnicity: Non Hispanic
• Patient Race: White