MAUDE Adverse Event Report: MEDTRONIC MEDICAL COSTA RICA S.R.L. CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	1606200500
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from healthcare provider via distributor regarding a patient underwent spinal therapy.Pre-op diagnosis of patient was adolescent idiopathic scoliosis.It was reported that, patient had some mild increase in pain nearly for 4 months after the surgery.Set caps did not hold the rods as needed.The rod came out of the set cap and screwhead after the surgery.X-ray performed on (b)(6)2025 shows rods no longer held by original construct at l3.The levels implanted were t3-l3.Procedure/technique performed during initial surgery was adolescent idiopathic scoliosis surgery.Patient underwent revision surgery, and the reported products were explanted.There were no further complications reported.
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.
Additional Manufacturer Narrative
Additional information: d4, h4.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): 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 ; 7635265677
• MDR Report Key: 21502065
• Report Number: 3014725904-2025-00026
• Device Sequence Number: 8007196
• Product Code: NKB
• UDI-Device Identifier: 00643169319462
• UDI-Public: 00643169319462
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131321
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 1606200500
• Device Catalogue Number: 1606200500
• Device Lot Number: 09954524
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 05/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 59 KG