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

Model Number	1608451030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Insufficient Information (4580)
Date of Event	03/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from an unknown source regarding a patient having plif extension l3/4 for adjacent segment degeneration at l3/4.It was reported that during a plif extension procedure implant experienced breakage.It was confirmed that no fragment of the implant remained in the patient.No patient complications or symptoms have been reported as a result of this event.
Additional Manufacturer Narrative
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.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
Additional information was received via manufacturer representative that the rod fracture was identified intra-operatively when revision surgery was performed as it is not possible to identify rod fracture via imaging.It is unknown to what degree the rod fracture contributed to the adjacent segment degeneration.
Additional Manufacturer Narrative
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: CD HORIZON® ASTUTE¿ SPINAL SYSTEM
• Common Device Name: POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; de 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; de 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21906691
• Report Number: 1030489-2025-01838
• Device Sequence Number: 17198876
• Product Code: NQP
• UDI-Device Identifier: 00763000312923
• UDI-Public: (01)00763000312923(17)310615(10)62PG
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K191066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 1608451030
• Device Catalogue Number: 1608451030
• Device Lot Number: 62PG
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 06/15/2023
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 102 KG