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

Model Number	55750025545
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via manufacturer representative regarding patient underwent t12 vertebroplasty + t11¿l1 percutaneous pedicle screw (pps) fixation revision surgery for extension.It was reported that currently t9-l1 was fixed, but the right l1 fenestrated screw broke below the screw head.The left l1 fenestrated screw is bent.Reoperation is scheduled for extending to l2 and l3.The tip of the screw is planned to remain in place.Additional screws were placed at l2 and l3, and fixation was completed.There were no further complications or symptoms reported regarding the event.Additional information was received that reoperation was performed for the adjacent segment disorder.Screws were added at th9 and th10, and fixation was extended.After that, screw fracture and bending occurred.The adjacent segment disorder occurred at voyager implant and no implant malfunction was observed.Additional information was received via manufacturer representative that there is no plan to remove the implant.It is unknown for the cause of adjacent segment disease.
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.G2: country of origin is japan.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 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: 25793358
• Report Number: 2647346-2026-00383
• Device Sequence Number: 18389052
• Product Code: NKB
• UDI-Device Identifier: 00763000149581
• UDI-Public: (01)00763000149581(17)290924(10)H5993129
• 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): 07/13/2026

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: 55750025545
• Device Catalogue Number: 55750025545
• Device Lot Number: H5993129
• 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: 06/15/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 09/24/2024
• 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