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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: ms b_unk_hardware, serial/lot #: unknown, udi#: unknown 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.H6: dextroscoliosis, adjacent level degeneration.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding a patient with clinical id (b)(6) and study id (b)(6).Description: adjacent level degeneration at l2-l3 onset date: (b)(6) 2022 interventions: action subtype: ae result in hospitalization; action result: y action date: (b)(6) 2023, end date of the hospitalization: (b)(6) 2023 action subtype: drug therapy; action result: yes action subtype: surgical treatment; action result: yes outcome status: not recovered/not resolved diagnostics action type: action subtype: x-ray1 action result: mild lumbar dextroscoliosis, action date: (b)(6) 2022 action subtype: mri without contrast2 action result: stenosis, action date: (b)(6) 2023 action subtype: were any diagnostic test performed action result: y comments: adverse event info: does the adverse event involve a lumbosacral spinal level: yes; levels involved: l2-l3 add surgical proc date - (b)(6) 2023 details surg proc - tlif l2/l3 and l5/s1, posterior instrumentation removal at l3/l5 with posterolateral arthrodesis, segmental inst rumentation at l2/s1.Is the additional surgical procedure an elective removal - yes, 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 - yes does the additional surgical procedure involve a spinal level - yes add.Surg: if yes, levels involved - l2-l3, l3-l4, l4-l5, l5-s1 the additional surgical procedure involve an explant related to the study procedure: cause of explantation - adjacent level decompression and fusion findings for explantation - 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 - solid evidence of fusion at l3/l5 worsening dextroscoliosis of 10 degrees noted at l2/l3 level.Preoperatively measured at 7 degrees.Mri (b)(6) 2023: moderately severe stenosis at l2/l3 with ap diameter reduced to 4 mm.(b)(6) 2023: posterolateral and intervertebral arthrodesis was performed at l2/l3 with bilateral laminectomy, decompression, segmental instrumentation, and placement of intervertebral device.Site seriousness assessment: medical intervention: yes, hospitalization: yes severity of ae: severe site related assessment: possibly related to capstone peek spinal system implant, posterior supplemental fixation system and study procedure: tlif at l3/l5 sponsor assessment (oc muo): causal related to surgical procedure with wide laminectomy; not related to tlif grafting; possibly related to capstone peek; not related to posterior supplemental fixation.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18099023
• Report Number: 1030489-2023-00739
• Device Sequence Number: 17643438
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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: 10/17/2023
• Initial Report FDA Received Date: 11/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White