CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT UNDERWENT T12 VERTEBROPLASTY + T11¿L1 PERCUTANEOUS PEDICLE SCREW (PPS) FIXATION REVISION SURGERY FOR EXTENSION. IT WAS REPORTED THAT CURRENTLY T9-L1 WAS FIXED, BUT THE RIGHT L1 FENESTRATED SCREW BROKE BELOW THE SCREW HEAD. THE LEFT L1 FENESTRATED SCREW IS BENT. REOPERATION IS SCHEDULED FOR EXTENDING TO L2 AND L3. THE TIP OF THE SCREW IS PLANNED TO REMAIN IN PLACE. ADDITIONAL SCREWS WERE PLACED AT L2 AND L3, AND FIXATION WAS COMPLETED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT REOPERATION WAS PERFORMED FOR THE ADJACENT SEGMENT DISORDER. SCREWS WERE ADDED AT TH9 AND TH10, AND FIXATION WAS EXTENDED. AFTER THAT, SCREW FRACTURE AND BENDING OCCURRED. THE ADJACENT SEGMENT DISORDER OCCURRED AT VOYAGER IMPLANT AND NO IMPLANT MALFUNCTION WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN TO REMOVE THE IMPLANT. IT IS UNKNOWN FOR THE CAUSE OF ADJACENT SEGMENT DISEASE.

Additional Manufacturer Narrative

E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. G2: COUNTRY OF ORIGIN 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.