CD HORIZON FENESTRATED SCREW SET

Additional Manufacturer Narrative

B1. ADVENT/PROD PROB CORRECTED. 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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 POSTERIOR SP INAL FUSION FOR AN INDICATION OF TH12 VERTEBRAL FRACTURE. IT WAS REPORTED THAT DURING CEMENT INJECTION INTO THE L2 FSN, THE CEMENT WAS LEAKED TO THE BLOOD VESSEL-LIKE SITE OUTSIDE THE VERTEBRAL BODY. THE CEMENT WAS CONFIRMED IN THE IN THE RIGHT ATRIUM IN THE POSTOPERATIVE CT. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 AND A DRY SHEATH AND A SNARE CATHETER WERE INSERTED THROUGH THE NECK TO REMOVE CEMENT THAT HAD ENTERED THE RIGHT ATRIUM. AS FOR THE CEMENT AROUND THE SPINE, IT IS UNLIKELY THAT IT WILL BE REMOVED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

A: SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. G2: THE COUNTRY OF THE EVENT IS JAPAN. 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.