MAUDE Adverse Event Report: MEDTRONIC MEDICAL COSTA RICA S.R.L. CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	5540030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for scoliosis at t2-pelvis.It was reported that the set cap disassembled from the rod and screw head.The patient experienced post-operative pain.Solid fusion was achieved, as confirmed by x-ray imaging.No additional surgery or treatment was performed as a result of this event.Additional information was received that there was no revision surgery planned.
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.
Additional Manufacturer Narrative
Radiographic image assessment indicated that antero posterior x-ray -posterior fusion construct to ilium.Upper levels not visualized.The set screw on one of the ilium is out of the screw tulip.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.
Additional Manufacturer Narrative
H3: product analysis: part # 5540030; lot # 0036624c visual and optical examination revealed thread crest/flank damage; this damage appears to have initiated at or near the start of the thread and is evident around the damaged portion of the thread.Functional evaluation with sample bone screw revealed the set screw was unable to be fully engaged.The above observations are consistent with misalignment of the bone screw and set screw threads during construct assembly.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® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer (Section G): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24452421
• Report Number: 3014725904-2026-00032
• Device Sequence Number: 9310807
• Product Code: KWP
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5540030
• Device Catalogue Number: 5540030
• Device Lot Number: 0036624C
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/18/2026; 05/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/15/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Unknown