MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® FENESTRATED SCREW SET; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	55750027540
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider regarding a patient having transcutaneous posterior fixation using a cement screw with 2a-2b for dish fracture and compression fracture and transcutaneous vertebroplasty using bkp at levels t9-l2.It was reported that post surgery, the cement leaked into the vein and flowed into the pulmonary artery.This was discovered after the procedure, and the patient was asymptomatic at the time of discovery.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that the mixer had no malfunction.Regarding the kits and screws, there was a small possibility that they may have caused the cement leakage but this was not confirmed.There was no change in the patient's condition and no additional treatment or procedure is being performed as a result of this event.But the patient was found to have stomach cancer while he was in the hospital (waiting for recovery), and that he would perform a gastric cancer operation which was unrelated to this event.Therefore, it is unknown whether he has recovered or not.Additional information was received from the manufacturer representative, indicating that the leak during the filling of cement in the vertebral body was presumed to have occurred at the tip of the bone filler device (bfd).However, the exact location of the leak has not been definitively determined.
Additional Manufacturer Narrative
B2: outcome attributed to adverse event is pulmonary embolism.E1: first name and last name of initial reporter is unknown.G2: country of event - 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: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: 22470143
• Report Number: 2647346-2025-00018
• Device Sequence Number: 14511827
• Product Code: PML
• UDI-Device Identifier: 00763000149161
• UDI-Public: (01)00763000149161(17)270719(10)H5779412
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 55750027540
• Device Catalogue Number: 55750027540
• Device Lot Number: H5779412
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 07/19/2022
• 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