CD HORIZON FENESTRATED SCREW SET

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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T12 R PLF (PPS) FOR AN INDICATION OF COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN CEMENT WAS INSERTED INTO THE CEMENT SCREW, LEAKAGE OCCURRED FROM THE HEAD. THE TIP ALSO SOLIDIFIED, RESULTING IN AN EXTENSION OF THE OPERATION TIME TO REMOVE THE TIP. IN ORDER TO REMOVE THE TIP, LOAD WAS APPLIED TO THE SCREW, CAUSING THE SCREW TO LOOSEN, SO REPLACEMENT WAS PERFORMED. THE DELAY OF LESS THAN 60 MINS REPORTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.