MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel CD HORIZON® SOLERA® VOYAGER¿ Spinal System; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6540530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, distributor) regarding a patient h aving spinal therapy.It was reported that during lumbar vertebral implant procedure involving placement of a solera voyager screw, rod positioning, and locking cap tightening, the ridges detached from the locking cap.The physician replaced the affected locking cap with a different locking cap.No patient complications, injury, hospitalization, or medical or surgical intervention to prevent permanent impairment were reported as a result of this event.Additional information was received that reporting that after the pedicle screw and rod were placed, the physician attempted to tighten the locking screw (6540530) clockwise but noticed it was not tightening properly.Upon removing and inspecting the device, the physician observed that one of the ridges had detached from the locking mechanism and the other ones were severely damaged; consequently, a different device was used, which functioned properly.There was no issue with the rod, it was only with the locking screw.
Additional Manufacturer Narrative
H6: the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 ; +1(763)526-5677
• MDR Report Key: 50880920
• Report Number: 2647346-2026-00534
• Device Sequence Number: 9826998
• Product Code: NKB
• UDI-Device Identifier: 00643169750241
• UDI-Public: (01)00643169750241(11)260105(10)0103172C
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 6540530
• Device Catalogue Number: 6540530
• Device Lot Number: 0103172C
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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
• Patient Sex: Unknown