MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55750027550
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/25/2026
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 fixat ion procedure at l1¿l3.The procedure was performed as a revision surgery following a prior bkp at l2 for osteoporotic compression fracture.It was reported that during the procedure, a gap between the locking outer sleeve and the tab extender cap was noticed.The physician was consulted and indicated that it should be fine as the button could not be pressed.However, cement leakage was confirmed under imaging.The screw was removed and inserted again to address the issue.Prior revision surgery was performed for instability of the adjacent vertebral bodies, described as adjacent segment disease, and not due to a cement product issue.It was also confirmed that no issue was identified with the cement itself and that the reported cement leakage during the current procedure was attributed to the fenestrated screw issue, specifically the gap between the locking outer sleeve and tab extender cap.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H6 - the device was returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 25516228
• Report Number: 2647346-2026-00333
• Device Sequence Number: 21484345
• Product Code: NKB
• UDI-Device Identifier: 00763000149185
• UDI-Public: (01)00763000149185(17)310120(10)H6117581
• 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: 2026
• Device Explanted Year: 2026
• 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): 06/16/2026

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: 55750027550
• Device Catalogue Number: 55750027550
• Device Lot Number: H6117581
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 01/20/2026
• 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