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

Model Number	559200029
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is unknown.H6: neither the device nor films of applicable imaging studies were 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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for l2-pelvis.It was reported that it was hard to know which set screw from this pack is loose.One of the set screws is no longer in the screw tulip after it was broken off during the case.The right l2 set screw has backed out of the screw¿s tulip.Surgeon noticed set screw out of position on post op follow x-ray.Surgeon did not indicate a symptoms related to the loose set screw.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative stating that the set screw is still in the patient and the replacement procedure is scheduled for (b)(6) 2025.The procedure involved was transforaminal lumbar interbody fusion involving the l2 vertebra fused to the pelvis and that there was no delay in the procedure.No specific complication that i was made aware of with this patient.Level implanted: the loose set screw is at right l2.Additional information was received from the manufacturer representative stating that hcp removed the set screw, and then replaced it with a new one to ensure proper fixation.After removal, photos of the set screw were taken and attached for documentation or further review.Additional information was received from the manufacturer representative stating that the explanted set screw was discarded by the hospital.

• Brand Name: CD HORIZON® 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: 24092363
• Report Number: 2647346-2026-00025
• Device Sequence Number: 21414490
• Product Code: NKB
• UDI-Device Identifier: 00763000972776
• UDI-Public: (01)00763000972776(17)300911(10)H6086156
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 559200029
• Device Catalogue Number: 559200029
• Device Lot Number: H6086156
• 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: 12/22/2025
• Initial Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 09/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male