MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	779115555
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	08/22/2025
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 healthcare provider (hcp) via a manufacturer representative regarding an event which occurred post a 2 level open posterior thoracolumbar fusion procedure in a patient diagnosed with spinal stenosis.It was reported that the patient had an extension of fusion done on the thoracic region.First surgery was performed using non-medtronic products.Medtronic connectors were used to extend the construct.Patient scan indicated that the connectors have come loose and the surgeon needs to do a revision surgery to remove lose connectors and use long rods as an alternative to connectors. there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B5: event details 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
There is no plan to perform a revision surgery.

• 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 ; 7635265677
• MDR Report Key: 23739123
• Report Number: 2647346-2025-00233
• Device Sequence Number: 20949808
• Product Code: KWP
• UDI-Device Identifier: 00613994739353
• UDI-Public: 00613994739353
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K101074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 779115555
• Device Catalogue Number: 779115555
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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 Age: 73 YR
• Patient Sex: Male