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

Model Number	55751025545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	07/08/2025
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 transcutaneous vertebral body reduction for l1 burst fracture (t11 to l1 fixation) it was reported that the screws were broken.The broken screw head came in contact with the skin, and it caused back pain.Initial surgery was performed on (b)(6) 2025.During the initial surgery, 11 was fixated to l1.Vf was used to percutaneously reduce the vertebral body.The patient was instructed to wear a corset and rest for 3 months after the surgery.The status of compliance is unknown.The patient complained of back pain starting from the 4th month; upon image evaluation, a correction loss was observed, and a shaft fracture was confirmed in the right side of the head screw and the left side of the caudal screw.It was confirmed that the shaft was broken on the right side of the head screw and the left side of the caudal screw.The shaft and screw head were also removed using the removable kit.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
E1: initial reporter details are unknown g2: country of origin is japan 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.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• 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: 22673434
• Report Number: 2647346-2025-00042
• Device Sequence Number: 7495765
• Product Code: NKB
• UDI-Device Identifier: 00763000150594
• UDI-Public: 00763000150594
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 55751025545
• Device Catalogue Number: 55751025545
• Device Lot Number: UNKNOWN
• 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: 07/08/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown