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

Model Number	55750026540
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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 formation/transcutaneous posterior fusion for osteoporotic vertebral fracture.It was reported that during cement fi lling of the cement screw; cement leaked to the screw head.Because cement leaked to the screw head, the cement delivery guide tip was retained.The planned percutaneous surgery ended up not being entirely percutaneous, resulting in a significantly larger incision being made.There was a delay of greater than 60 minutes in the overall procedure time.A total of 8 screws were used in the fixed range th11/l3.Only the right side of l2 leaked cement on the screw head side.The guide tip could be removed, but after inserting the rod, the set screw could not be inserted on the right side of l2.For the right side of l2, the set screw installation was abandoned.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B2: other - the planned percutaneous surgery ended up not being entirely percutaneous, resulting in a significantly larger incision being made.There was a delay of greater than 60 minutes in the overall procedure time.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: 22870449
• Report Number: 2647346-2025-00070
• Device Sequence Number: 9081614
• Product Code: NKB
• UDI-Device Identifier: 00763000148829
• UDI-Public: (01)00763000148829(17)300428(10)H6049344
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: 55750026540
• Device Catalogue Number: 55750026540
• Device Lot Number: H6049344
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 04/28/2025
• 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: Other
• Patient Sex: Unknown