MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® FENESTRATED SCREW SET; CEMENT, BONE, VERTEBROPLASTY

Model Number	55750026540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic image assessment: 1- axial ct construct material screw posterior to vertebral body in spinal canal 2- axial ct different slice, cement seen in spinal canal 3- sagittal ct, cement seen in 5 levels appears posterior to the vertebral body at second level for fusion 4- ap x-ray of fusion construct t4-l3 5- lateral x-ray of construct 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 healthcare provider regarding a patient having th12/l1/l2 tlif th11/l3 posterior spinal fusion due to osteoporotic compression fracture.It was reported that postoperative ct revealed medial breach of the left l2 screw and cement leakage into the spinal canal.The leakage is considered to be due to the screw dislodging into the spinal canal.The cement leakage occurred intraoperatively, and it was identified postoperatively.There was no patient symptoms reported.There is currently no plan to explant the screw.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• 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: 23814512
• Report Number: 2647346-2025-00251
• Device Sequence Number: 9286027
• Product Code: NDN
• UDI-Device Identifier: 00763000148829
• UDI-Public: 00763000148829
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 55750026540
• Device Catalogue Number: 55750026540
• Device Lot Number: UNKNOWN
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/16/2025
• 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