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

Model Number	1608451060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Stenosis (2263); Depression (2361); Spinal Cord Injury (2432); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number is unknown.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 a patient via manufacturer representative regarding a peek rod used in spinal therapy.It was reported that the patient had peek rods implanted during their surgery (b)(6) 2022 which broke post op.The patient was unaware and the broken rod was undetectable.Patient experienced extreme pain and hardship as a result.This was corrected on (b)(6) 2025.
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.
Additional Manufacturer Narrative
B5: event description 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.
Event or Problem Description
Additional information was received from the legal comment report (lcr) that the initial surgery happened was spinal fusion in (b)(6) 2022 aimed to address severe stenosis and foraminal spaces in between the vertebrae spaces where the nerves run through and loss of function.However, by (b)(6), 2023, mri results revealed tears, bulges, and stenosis in the fused areas, leading to the need for hardware removal and a second fusion.By (b)(6) 2025, the patient faced significant functional decline, including difficulty walking, dragging the right leg, extreme fatigue, and depression.

• 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 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21956973
• Report Number: 1030489-2025-01866
• Device Sequence Number: 21129297
• Product Code: NQP
• UDI-Device Identifier: 00763000312985
• UDI-Public: 00763000312985
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 1608451060
• Device Catalogue Number: 1608451060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/22/2025
• Initial Report FDA Received Date: 05/04/2025
• Supplement Report FDA Received Date: 07/17/2025; 08/12/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown