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

Model Number	2991022
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Country of origin is china.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.
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding a patient with clinical id (b)(6), study id (b)(6) and incident type ae subevent number: 3.Primary diagnosis: stenosis description: low back pain onset date: 2024-10-14 outcome status: not recovered/ not resolved interventions: action subtype: ae result in hospitalization action result: no action subtype: any other action(s) taken action result: no action subtype: did the ae result in any treatment action result: yes action subtype: drug therapy action result: yes action subtype: physical therapy action result: yes site seriousness assessment: there is no congenital anomaly, death, disability, hospitalization, life threatening, medical intervention and severity of adverse event is mild.Site related assessment: it is probable related to posterior supplemental fixation system and not related to capstone peek spinal sy stem, tlif grafting, study procedure.Adverse event info: does the adverse event involve a lumbosacral spinal level: no diagnostics: action type: diagnostic action subtype: ct without contrast1 action result: internal fixation and the fusion device may become loose action date: 2025-06-19 action type: diagnostic action subtype: were any diagnostic test performed action result: yes event: it was reported that the patient suffered from lower back pain along with pain in the finger joints.Medication was prescribed for treatment.Additional information was received from manufacturer representative that there is no revision surgery planned or scheduled for the removal of loosened fusion device.Additional information was received that site related assessment: it is probable related to posterior supplemental fixation system, capstone peek spinal system and not relat ed to tlif grafting, study procedure.Additional information was received that via manufacturer representative that ct lumbar vertebral 3d imaging was done on (b)(6) 2025 and indicated possible loosening of the internal fixation and fusion cage.
Additional Manufacturer Narrative
D6a.Implant date is updated.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,de 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24374487
• Report Number: 3011795235-2026-00008
• Device Sequence Number: 14865433
• Product Code: MAX
• UDI-Device Identifier: 00613994291004
• UDI-Public: (01)00613994291004(17)300314(10)H5746212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 2991022
• Device Catalogue Number: 2991022
• Device Lot Number: H5746212
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 03/14/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian