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

Model Number	6541104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having posterior fixat ion was performed following l2/5 xlif, with fns mas used for cement augmentation at l2 and l5 for kyphosis.It was reported that three months after initial surgery, three set screws became dislodged on the left side of l2 and both sides of l5, resulting in lower back and lower limb pain and requiring repeat surgery.During the repeat procedure, the dislodged screws and rods were explanted and replaced, and the patient was hospitalized for this intervention. there were no further complications reported regarding the event.
Additional Manufacturer Narrative
E1: first name and last name of initial reporter is unknown.B2: outcome attributed to adverse event is additional surgery and hospitalization.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
Radiographic image review states, anteroposterior lateral xray l2-5 interbody fusion grafts were present at levels l2-3, l3-4, l4-5.Anteroposterior lateral xray, the set screw at l2 and l5 appear dislodged in (1) compared to (2).Pre-op anteroposterior lateral xray.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
H3: product analysis of product: 6541104, lot: h5953788 visual and optical examination revealed that there were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.Functional evaluation of the returned implant with a sample bone screw confirmed the set screw was able to engage and thread into the head of the bone screw without issue.The bottom node of the set screw shows signs of off axis/ uneven wear from the seating of the rod.There is some smearing/damaged to the nodes.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® SOLERA® VOYAGER¿ 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: 23348247
• Report Number: 2647346-2025-00161
• Device Sequence Number: 7807647
• Product Code: NKB
• UDI-Device Identifier: 00763000211219
• UDI-Public: (01)00763000211219(17)290507(10)H5953788
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 6541104
• Device Catalogue Number: 6541104
• Device Lot Number: H5953788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 12/18/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown