CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T11 VERTEBRAL B ODY REPLACEMENT PROCEDURE AND POSTERIOR FIXATION FROM T8 TO L2 USING A PERCUTANEOUS PEDICLE SCREW FIXATION TECHNIQUE FOR T11 COMPRESSION FRACTURE. IT WAS REPORTED THAT WHILE INJECTING CEMENT INTO THE LEFT SCREW AT L2 USING THE MEDTRONIC CEMENT DELIVERY SYSTEM, CEMENT LEAKED TOWARD THE SCREW HEAD SIDE DURING INJECTION. AS A RESULT, THE DEVICE WAS REMOVED AND THE LEAKED CEMENT WAS REMOVED INTRAO PERATIVELY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

D4: LOT NUMBER IS UNKNOWN E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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.