CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Additional Manufacturer Narrative

D.4. LOT# IS UNKNOWN. 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 SPINAL THERAPY. IT WAS REPORTED THAT CEMENT LEAKAGE OCCURRED FROM THE SCREW DURING PEDICLE SCREW CEMENTATION. IT WAS UNKNOWN IF THERE WAS ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS CONFIRMED THAT THE CEMENT LEAKAGE OCCURRED THROUGH THE SCREW TULIP. THE ISSUE WAS WITH FNS SCREW ONLY. CEMENT CONSISTENCY WAS AS USUAL. THERE WAS NO CEMENT ISSUE. THE SURGERY HAS BEEN COMPLETED WITH A SIGNIFICANT DELAY.