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

Model Number	55750026545
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.G2: country of origin is japan.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.¿this regulatory report is being submitted due to retrospective review.¿ 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 healthcare provider (hcp) via a manufacturer representative regarding a patient having l3 balloon kyph oplasty (bkp) for secondary fracture (compression fracture).It was reported that during the injection of 0.8cc of fns cement into the right side of l2, extra vertebral leakage was identified through intraoperative fluoroscopy.Postoperative ct imaging revealed that the cement had reached the inferior vena cava.It has been confirmed that the patient is asymptomatic at this time; however, after consulting with the cardiology department, anticoagulant therapy will be initiated to prevent pulmonary embolism.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received that there was no malfunction is reported with unknown voyager implant.It was added to this event for a vertebral fracture post initial surgery.Additional information was received from the manufacturer representative that the cement leaked from the voyager fenestrated screw.There were no malfunctions with fns tips and bone filler devices.They were used along with fenestrated screw.There are no defective events such as deformation of the product.There is no product malfunction from the initial surgery.Additional information was received that there was no relation between vertebral fracture and the explanted unknown voyager implant.Additional information was received that on wednesday, january 21, a cement removal case was performed at the department of cardiovascular surgery.It is said that the cement of this event cracked and separated into two around 3 months after the operation.After that, no cement movement was observed, and the patient's condition did not change (asymptomatic).As a result of consulting with the cardiovascular system, a cement removal case was performed on wednesday, (b)(6) an ivc filter was installed and cement was removed using a snare, but the cement was adhered to and several attempts were made to remove it, but the cement did not move and could not be removed, and ope was terminated.After surgery, patients continue to receive anticoagulants, although they are asymptomatic.Additional information was received that the cement could not be removed.The patient is continuing to receive anticoagulant therapy.Additional information was received that it was previously stated that anticoagulant medication was continued; however, the correct information is that no medication was administered.

• Brand Name: CD HORIZON® FENESTRATED SCREW 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: 25445333
• Report Number: 2647346-2026-00304
• Device Sequence Number: 9533425
• Product Code: NKB
• UDI-Device Identifier: 00763000148836
• UDI-Public: (01)00763000148836(17)290403(10)H5944050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 55750026545
• Device Catalogue Number: 55750026545
• Device Lot Number: H5944050
• 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: 04/06/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 04/03/2024
• 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