CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

RADIOGRAPHIC IMAGE REVIEW RESULTS: 1. LATERAL X-RAY T12-L3 FUSION CEMENT AUGMENTATION T12, L1, L2 2. AP XRAY ROD SCREW CONSTRUCT APPEARS INTACT, NO DEVICE MALFUNCTION EVIDENT ON IMAGES. 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.

Additional Manufacturer Narrative

H3: VISUAL INSPECTION CONFIRMED ONLY THE BREAK OFF TABS WERE RETURNED. 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 L2 BKP (BALLOON KYPHOPLASTY) TH12/L3 POSTERIOR FIXATION THERAPY FOR PRIMARY OSTEOPOROSIS AND L2 COMPRESSION FRACTURE. IT WAS REPORTED THAT BKP AND PS WERE INSERTED INTO L2. AFTER THAT, INSERTED L1 PS, BUT IT WAS NOT VERY EFFECTIVE, SO CHANGED THE FIXED RANGE TO TH12. FM WAS PERFORMED ON TH12 AND L3. AFTER FILLING THE CEMENT, THE DELIVERY GUIDE WAS REMOVED, BUT THE TIP ON BOTH SIDES OF TH12 REMAINED INSIDE THE HEAD. ON THE LEFT SIDE, THE DELIVERY GUIDE WAS REINSERTED AND RE-ATTACHMENT AND REMOVAL WERE POSSIBLE, BUT ON THE RIGHT SIDE, IT DID NOT COME OFF AT ALL. IT COULD NOT BE PERFORMED USING ANY TOOL THAT CAN GRASPED OR KOCHER FORCEPS. THE TAB TRIED FOLDED ON ONE SIDE AGAIN BUT IT DID NOT WORK. THE TABS WAS FOLDED ON BOTH SIDES AND TRIED TO GRAB IT WITH PLIERS IN THE MINI-OPEN STATE AND PULL IT OUT, BUT IT WAS IMPOSSIBLE. AFTERWARDS, CEMENT WAS FOUND AROUND THE TIP (INSIDE THE HEAD). THEREFORE, THE PROCESS OF SCRAPING AND PULLING WITH A CHISEL IS REPEATED MANY TIMES. MORE THAN 40 MINUTES HAVE PASSED SINCE THE REMAIN WAS CONFIRMED IN THE TIP. AFTER THAT, WITH MOST OF THE CEMENT HAVING BEEN SCRAPED OFF, IT COULD BE REMOVED BY PULLING IT OUT WITH PLIERS. IT WAS LATER DISCOVERED THAT CEMENT WAS ALSO AROUND THE THREADS INSIDE THE SCREW, SUGGESTING THAT THE SET SCREW MIGHT NOT BE ABLE TO FIT. THEREFORE, ADDITIONAL CUTTING WAS DONE WITH A CHISEL, THE ROD WAS INSTALLED, AND THE FINAL TIGHTENING WAS COMPLETED. ALTHOUGH THE SET SCREW WAS ABLE TO BE FINALLY TIGHTENED, IT COULD NOT BE CONFIRMED HOW MUCH THE CEMENT WAS AFFECTING IT. THE POSSIBILITY THAT A PORTION OF THE CEMENT REMAINED IN THE BODY DURING THE CEMENT REMOVAL CANNOT BE DENIED. AFTER THAT, THE INCISION WAS CLEANED MORE THAN NECESSARY, AND CLOSED IT. THERE WAS NO PROBLEM WITH BONE FILLER DEVICE AND CEMENT DELIVERY GUIDE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

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.