MAUDE Adverse Event Report: Medtronic Medical Costa Rica S.R.L. CD HORIZON® Spinal System; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1603200500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a rod used for revision of two l evel anterior lumbar interbody fusion therapy and posterior hardware revision for pre-operative diagnosis of spinal stenosis.It was reported that the patient has had multiple procedures done.On (b)(6) 2019, the patient underwent an l3-l5 lumbar spinal fusion.On (b)(6) 2026, the patient had a revision extension spinal fusion spanning t10-pelvis.Between this surgery and one month follow up on (b)(6) 2026, the patients rods broke just above the s1 screws.On (b)(6) 2026, the patient underwent a revision and had an anterior lumbar interbody fusion therapy done at l4-l5 and l5-s1 levels and then had a posterior revision where extra pelvic screws were added along with secondary rods for more support.There were no further complications reported regarding the event.
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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50470131
• Report Number: 3014725904-2026-00083
• Device Sequence Number: 10264522
• Product Code: KWP
• UDI-Device Identifier: 00613994990686
• UDI-Public: (01)00613994990686(11)251111(10)0092378C
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 1603200500
• Device Catalogue Number: 1603200500
• Device Lot Number: 0092378C
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 11/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male