CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF PART# 55750026540, LOT# H5777945 VISUAL INSPECTION CONFIRMED THE CEMENT HAS LEAKED OUT AND DRIED ALL OVER THE SCREW. UNABLE TO DETERMINE ROOT CAUSE OF LEAK. 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

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.

Description of Event or Problem

INFORMATION WAS RECEIVED VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN LUMBAR SPINAL FUSION (XLIF) WITH PERCUTANEOUS PEDICLE SCREW PROCEDURE FOR LUMBAR CANAL STENOSIS AND CONCURRENT OSTEOPOROSIS. LEVELS IMPLANTED WAS L3/4/5. IT WAS REPORTED THAT THE CEMENT DELIVERY GUIDE WAS ATTACHED AFTER SCREW INSERTION. BONE CEMENT MIXED BUT AFTER 6 MINUTES LATER HARDNESS WAS CONFIRMED AND THEN REFILLED. THE CEMENT DELIVERY GUIDE WAS REMOVED AFTER REFILL, BUT THE GUIDE TIP REMAINED IN THE CROWN. ATTEMPTS WERE MADE TO REMOVE THE DEVICE USING A COCHLEAR OR NEEDLE-NOSE PLIERS, BUT THE DEVICE COULD NOT BE REMOVED. IT WAS CONFIRMED THAT THE CEMENT HAD LEAKED INTO THE HEAD, SO IT WAS REMOVED USING COUNTER TORQUE. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO DEFECT ASSOCIATED WITH BONE FILLER DEVICE AS IT WAS USED DURING CEMENT INJECTION. THERE WAS NO CEMENT EXTRAVASATION.