MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	54840006545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Information was received from clinical study via healthcare provider (hcp) and a manufacturer representative regarding a patient with clinical id: (b)(6).The patient experienced pseudarthrosis (nonunion) with an onset dated on (b)(6) 2025.This adverse event is considered serious due to the need for hospitalization and medical/surgical intervention; it was not life-threatening, did not result in disability, and did not involve a congenital anomaly or death.The site became aware of the event on 05 dec 2025, and it occurred in the post-surgical period following the index spinal procedure.The index procedure was an implanted spinal surgery performed on (b)(6) 2024.Clinically, the patient reported persistent postoperative pain.The initial differential diagnosis included infection versus pseudarthrosis.Preoperative diagnostic testing was negative for inflammation, decreasing the likelihood of an infectious process.Pseudarthrosis was subsequently confirmed intraoperatively during an additional spinal surgery performed on (b)(6) 2025.The patient required a new hospitalization beginning on (b)(6) 2025, with discharge on (b)(6) 2025.Interventions included the additional spinal surgery on (b)(6) 2025, application/use of a brace, and medication administration; opioid or narcotic analgesics were adjusted and/or administered during the course of treatment.The adverse event resulted in treatment, and the patient¿s outcome was recovered/resolved by on (b)(6) 2025.The site¿s relatedness assessment characterized the event as probably related to the device (rod and screw) and probably related to the procedure (additional surgery).The site seriousness assessment documented hospitalization and medical/surgical intervention as present, with death, life-threatening condition, disability, and congenital anomaly not present.
Additional Manufacturer Narrative
B5.Desc evt problem updated.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
(b)(6) 2026, update received hydromorphone 0.5 mg iv prn; start (b)(6) 2025; indication: post-lumbar surgery pain.Ketamine 20 mg iv prn; start/end (b)(6) 2025; indication: anesthesia for additional lumbar spine surgery; corresponding ae: 009 ((b)(6) 2025) pseudarthrosis.Methadone 10 mg iv prn; start/end (b)(6) 2025; indication: anesthesia for additional lumbar spine surgery; corresponding ae: 009 ((b)(6) 2025) pseudarthrosis.Diagnostics: neurological exam on (b)(6) 2025¿motor strength 5/5 in bilateral lower extremities; not clinically significant.(b)(6) 2026, update received comments: additional surgery: (b)(6) 2025; primary reason: adverse event related to additional spinal surgery.Procedure type: removal performed.Levels involved: t12, l1, l2, l3, l4, l5, s1.New medtronic cst alliance¿eligible devices implanted: yes.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; 7635265677
• MDR Report Key: 23960279
• Report Number: 2647346-2026-00007
• Device Sequence Number: 17545642
• Product Code: NKB
• UDI-Device Identifier: 00613994579614
• UDI-Public: 00613994579614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 54840006545
• Device Catalogue Number: 54840006545
• Device Lot Number: UNKNOWN
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/15/2026
• 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 Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White