MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	54840006545
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/21/2025
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)(6).It was reported that during an index surgery, there was a pull out of t12 screws with post junctional kyphosis, leading to hardware failure.An x-ray diagnostic test confirmed the pull out of t12 screws which was clinically significant.The outcome of this adverse event was not recovered/not resolved.No further complications reported.Site related assessment: adverse event probably related to the index surgery.Not related to a medtronic cst device.Sponsor assessment: assessment for product/therapy/procedure relatedness made by the sponsor was different from investigator.The adverse event was assessed as having a causal relationship with the index surgery.And had causal relationship with the study device.Additional information was received from the manufacturer representative that as per the device identification crf for the subject, however no indication of specific device relationship has been made by the site.Based on the nature of the event, sponsor chose a conservative assessment of device related until it can be ruled out with further information.There was no hospitalization or surgical intervention.Spinal level where treatment started was t12 and spinal level where treatment ended was s1.Location of bone graft was in the posterolateral space.
Additional Manufacturer Narrative
D4: lot number is unknown 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: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21430277
• Report Number: 1030489-2025-00860
• Device Sequence Number: 4349147
• Product Code: NKB
• UDI-Device Identifier: 00613994579614
• UDI-Public: 00613994579614
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• 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): 02/21/2025

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: 54840006545
• Device Catalogue Number: 54840006545
• Device Lot Number: SEE H11
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/21/2025
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White