CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

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 PERCUTANEOUS PE DICLE SCREW (PPS) FIXATION THERAPY FOR L1 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS REFILLED WITH FNS, BUT IT WAS NOT DELIVERED TO THE VERTEBRAL BODY AND LEAKED INTO THE SCREW HEAD. BOTH PLACES WERE RIGHT, TH12 AND L2. IT WAS NOT POSSIBLE TO OBTAIN THE FIXATION PROPERTIES THAT WERE ORIGINALLY EXPECTED. CEMENT REMAINED IN THE SCREW HEAD, MAKING IT IMPOSSIBLE TO INSTALL THE ROD. TH12 WAS REMOVED AND THE SCREW WAS RE-PLACED. L2 SEEMED TO HAVE BEEN ABLE TO REMOVE THE CEMENT AT FIRST GLANCE, BUT BECAUSE THE SET SCREW COULD NOT BE TIGHTENED COMPLETELY DUE TO THE REMAINING CEMENT NEAR THE CROWN, THE SET SCREW BURST OPEN DURING THE FINAL TIGHTENING, SO THE V5 TAB WAS COMPLETELY REMOVED AND THE ROD WAS RE-PLACED. THE SET SCREW DID NOT FIT INTO THE SCREW HEAD AND CAME LOOSE DURING THE FINAL FASTENING. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS # (B)(4), PART # 55750026545, LOT # H5749806, VISUAL INSPECTION CONFIRMED THE CEMENT HAS LEAKED IN THE HEAD OF THE SCREW. THE CEMENT LEAK APPEARS TO BE FROM THE FAILED ATTEMPT IN DELIVERING THE CEMENT IN THE VERTEBRAL BODY. 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.