MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., HU CD HORIZON® SOLERA® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6530530
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Pain (1994)
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 manufacturing representative regarding a patient undergone spinal therapy.It was reported that levels implanted was l4/l5/s1.No further complications were reported/anticipated.Rep confirmed that the tightening nut was not torqued to failure as per correct procedure.Pre op diagnosis of the event was pain due to micromovements as the system was not fixed.Clamping nut not tightened.The product explanted on (b)(6) 2025.

• Brand Name: CD HORIZON® SOLERA® SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23775009
• Report Number: 2647346-2025-00243
• Device Sequence Number: 10079681
• Product Code: NKB
• UDI-Device Identifier: 00643169750258
• UDI-Public: (01)00643169750258(17)301219(10)H5820316
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6530530
• Device Catalogue Number: 6530530
• Device Lot Number: H5820316
• 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: 11/12/2025
• Initial Report FDA Received Date: 12/10/2025
• Date Device Manufactured: 12/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female