MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel CD HORIZON® Spinal System; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840006560
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient with clinical id: (b)(4) and study id: (b)(4) having l3-l5 posterior spinal fixation and fusion therapy.It was reported that there has been failure of the right iliac set screw with some worsening of his positive sagittal balance and pill mismatch.There were no patient symptoms reported.  outcome status: recovering/ resolving action type: diagnostic, action subtype: x-ray-1 action result: ap and lateral scoliosis radiographs reveal l3 to ilium fusion with lateral interbody at l3-4 and anterior lumbar interbody fusion l5-s1.There has been failure of the right iliac set screw with some worsening of his positive sagittal balance and pill mismatch.No other instrumentation failure, action date: 2026-09-03 site related assessment: causal relationship with study device.Sponsor assessment: sponsor assessment not related to procedure, causal related to device.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
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.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): 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 ; +1(763)526-5677
• MDR Report Key: 50893920
• Report Number: 2647346-2026-00537
• Device Sequence Number: 6001429
• Product Code: KWP
• UDI-Device Identifier: 00613994971784
• UDI-Public: (01)00613994971784(11)241014(10)H5999524
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 55840006560
• Device Catalogue Number: 55840006560
• Device Lot Number: H5999524
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 10/14/2024
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 260 LB