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

Model Number	55720005550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
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 a product used for spinal fusion therapy in a patient with clinical id (b)(6), study name ailliance mdt22045cstail.It was reported that at the 12-month follow-up visit, it was noted that the subject had not fully fused at all treated levels and all the implanted devices did not appear stable and secure.There were no further patient complications or symptoms have been reported as a result of this event.There is no assessments made by sponsor, investigator and cec regarding the relatedness for product/therapy/procedure.Additional information was received via manufacturer representative that patient is doing well overall, and certainly much better than pre-op, and is quite satisfied with his current state.There is no need to go through another major surgery, despite the ct showing pseudarthrosis (nonunion) at the uppermost fusion level l1-2.As the l1 screws are grossly loosened, the likelihood of that segment going on to solid union is very low.As such, surgeon do not think that bone stimulator is likely to be of benefit and explained that it is essentially right now functioning as a non-fused level, simply stopped the surgery at l2 (l2 to pelvis construct).As long as the patient symptoms are minimal, aggressive intervention is not warranted and reassured that this is not grossly unstable and will not lead to catastrophic complication or significant neurologic deficit.

• 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: 23919816
• Report Number: 2647346-2025-00278
• Device Sequence Number: 13095927
• Product Code: NKB
• UDI-Device Identifier: 00643169761612
• UDI-Public: (01)00643169761612(17)320724(10)H5975931
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: 55720005550
• Device Catalogue Number: 55720005550
• Device Lot Number: H5975931
• 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: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 07/24/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 83 KG