CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS PULMONARY EMBOLISM. E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. G2: COUNTRY OF EVENT - JAPAN. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING TRANSCUTANEOUS POSTERIOR FIXATION USING A CEMENT SCREW WITH 2A-2B FOR DISH FRACTURE AND COMPRESSION FRACTURE AND TRANSCUTANEOUS VERTEBROPLASTY USING BKP AT LEVELS T9-L2. IT WAS REPORTED THAT POST SURGERY, THE CEMENT LEAKED INTO THE VEIN AND FLOWED INTO THE PULMONARY ARTERY. THIS WAS DISCOVERED AFTER THE PROCEDURE, AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF DISCOVERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE MIXER HAD NO MALFUNCTION. REGARDING THE KITS AND SCREWS, THERE WAS A SMALL POSSIBILITY THAT THEY MAY HAVE CAUSED THE CEMENT LEAKAGE BUT THIS WAS NOT CONFIRMED. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION AND NO ADDITIONAL TREATMENT OR PROCEDURE IS BEING PERFORMED AS A RESULT OF THIS EVENT. BUT THE PATIENT WAS FOUND TO HAVE STOMACH CANCER WHILE HE WAS IN THE HOSPITAL (WAITING FOR RECOVERY), AND THAT HE WOULD PERFORM A GASTRIC CANCER OPERATION WHICH WAS UNRELATED TO THIS EVENT. THEREFORE, IT IS UNKNOWN WHETHER HE HAS RECOVERED OR NOT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE, INDICATING THAT THE LEAK DURING THE FILLING OF CEMENT IN THE VERTEBRAL BODY WAS PRESUMED TO HAVE OCCURRED AT THE TIP OF THE BONE FILLER DEVICE (BFD). HOWEVER, THE EXACT LOCATION OF THE LEAK HAS NOT BEEN DEFINITIVELY DETERMINED.