MAUDE Adverse Event Report: MSD DEGGENDORF MFG CD HORIZON® ASTUTE¿ SPINAL SYSTEM; POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Model Number	1608451035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: rods were implanted on (b)(6) 2020 (month and year valid).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 was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred post a l 5-s1 arthrodesis and osteosynthesis on (b)(6) 2020 procedure in a patient.It was reported that the rods broke, patient had recurrence of pain at a distance and rods were explanted.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B5: event details 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.
Event or Problem Description
Event occurred post a lumbar posterior fusion procedure.

• Brand Name: CD HORIZON® ASTUTE¿ SPINAL SYSTEM
• Common Device Name: POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
• 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: 23894851
• Report Number: 3011795235-2025-00027
• Device Sequence Number: 4552435
• Product Code: NQP
• UDI-Device Identifier: 00763000312930
• UDI-Public: 00763000312930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1608451035
• Device Catalogue Number: 1608451035
• Device Lot Number: 08JR
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 12/05/2019
• 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 Sex: Unknown