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

Model Number	55750027540
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having posterior verte bral fusion at 9th thoracic vertebra - pelvis (left s1).Pre op diagnosis was pseudarthrosis following fourth lumbar vertebra compression fracture, fifth lumbar vertebra and sixth lumbar vertebra compression fractures.It was reported that during screw insertion, cement injection procedure was performed using this product on the left s1.Cement was injected into the vertebral body without issue up to approximately 1.6 cc, but when injecting the final 0.2 cc, a shadow was observed around the screw head on the x-ray image, and direct visualization confirmed a small amount of cement leakage.The leaked cement was removed as much as possible, and this did not interfere with the subsequent procedure.It was considered that the issue is not due to a defect in the cement itself.It was unable to be determined whether leakage was due to backflow within the screw or leakage from the tip.There were no patient symptoms reported.There were no further complications reported regarding the event.
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® FENESTRATED SCREW SET
• 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: 23959874
• Report Number: 2647346-2026-00006
• Device Sequence Number: 9473786
• Product Code: NKB
• UDI-Device Identifier: 00763000149161
• UDI-Public: (01)00763000149161(17)300328(10)H6042398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 55750027540
• Device Catalogue Number: 55750027540
• Device Lot Number: H6042398
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 03/28/2025
• 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
• Patient Sex: Unknown