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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Information was received from the health care professional via a manufacturer representative regarding a device used for posterior lumbar interbody fusion procedure.Levels implanted: l4-5 it was reported that during original fusion rods were found to be broken.The broken rods were explanted.There were no patient symptoms reported.There were no further complications reported regarding the event.

• 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: 24288863
• Report Number: 3011795235-2026-00006
• Device Sequence Number: 9388227
• Product Code: NQP
• UDI-Device Identifier: 00763000312923
• UDI-Public: (01)00763000312923(17)271126(10)27JP
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: 1608451030
• Device Catalogue Number: 1608451030
• Device Lot Number: 27JP
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 92 KG