CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

G2: COUNTRY OF EVENT (B)(6). 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION USING 2 ABOVE 2 BELOW PROCEDURE WAS PERFORMED FOR A VERTEBRAL FRACTURE AT TH8 DUE TO DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH). IT WAS REPORTED THAT DURING PROCEDURE, BONE CEMENT LEAKAGE WAS DETECTED INTRAOPERATIVELY INTO THE BLOOD VESSEL AT THE RIGHT TH7 AND RIGHT TH6 LEVELS, AND POSSIBLE LEAKAGE TOWARD THE POSTERIOR SIDE AT LEFT TH6 WHILE FILLING EACH VERTEBRAL BODY AND THE FILLING WAS STOPPED IMMEDIATELY UPON DETECTION, MINIMIZING THE EXTENT OF LEAKAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE OPINION AT THE END OF THE OPERATION WAS THAT THE TH6 LEFT SCREW WAS INSERTED FROM THE OUTSIDE AND THE CEMENT FLOWED LATERALLY, BUT AFTER THE OPERATION, THE CT REVEALED THAT THE SCREW WAS OUT OF BOUNDS IN THE INTERIOR AND THAT THE CEMENT HAD LEAKED INTO THE SPINAL CANAL. THERE IS NO OTHER PROBLEM WITH THE PATIENT AT THIS STAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN¿S POSTOPERATIVE ASSESSMENT WAS INCORRECT. AT THE TIME OF THE ADDITIONAL REPORT, IT WAS DISCOVERED THAT THE SCREW WAS OB. THERE WAS NO SCREW MIGRATION. THERE IS NO PLAN FOR EXPLANTATION OF THE SCREW.