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

Model Number	559200027
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from manufacturer representative regarding a patient having spinal therapy.It was reported that set screw loosened.  there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
B5: updated d4: lot number updated e1: facility updated.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
Additional information received from manufacturer representative that the therapy involved was posterior spinal fusion and there was no additional surgery scheduled.

• Brand Name: CD HORIZON¿ MODULEX¿ 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: 23531362
• Report Number: 2647346-2025-00208
• Device Sequence Number: 9065862
• Product Code: NKB
• UDI-Device Identifier: 00763000972752
• UDI-Public: (01)00763000972752(17)300611(10)H6061084
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 559200027
• Device Catalogue Number: 559200027
• Device Lot Number: H6061084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown