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

Model Number	54850016545
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: first name and last name of initial reporter is unknown g2: country of origin is vietnam.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 multiple sources (manufacturer representative, distributor) regarding a patient having voyager + cres cent surgery case.It was reported that during the surgical procedure involving decompression and l2-l3 disc replacement, four voyager screws were fixed into the l2-l3 vertebral bodies under c-arm fluoroscopic guidance.After placement of two disc crescent, the surgical team proceeded to insert six voyager screws, six set screw, and two rods.However, during the rod insertion maneuver, the break-off section of one voyager screw fractured.Upon inspection, the screw was deemed unusable and had to be replaced with a new one.There was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® SOLERA® 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: 23552633
• Report Number: 2647346-2025-00212
• Device Sequence Number: 9327158
• Product Code: NKB
• UDI-Device Identifier: 00643169491564
• UDI-Public: (01)00643169491564(11)250321(10)H6040883
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: Other
• Device Model Number: 54850016545
• Device Catalogue Number: 54850016545
• Device Lot Number: H6040883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 03/21/2025
• 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 Sex: Unknown