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

Model Number	55850016545
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
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 multiple sources (healthcare provider, distributor) regarding a patient having minimally invasive tran sforaminal lumbar interbody fusion (mis-tlif, l5¿s1) due to spinal degeneration.It was reported that after selecting the appropriate screw size for implantation, the screw was implanted and the rod was placed.However, when attempting to secure the rod, the nut c ould not be properly locked despite multiple attempts.The surgeon then replaced the screw with another screw of the same size, after which the nut was successfully locked and the surgery was completed smoothly.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ 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: 24375423
• Report Number: 2647346-2026-00078
• Device Sequence Number: 20252966
• Product Code: NKB
• UDI-Device Identifier: 00643169768277
• UDI-Public: (01)00643169768277(11)230623(10)H5870938
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55850016545
• Device Catalogue Number: 55850016545
• Device Lot Number: H5870938
• 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: 01/31/2026
• Initial Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 06/23/2023
• 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
• Patient Sex: Male