CD HORIZON® FENESTRATED SCREW SET

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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S(L6) 2 INTE RVERTEBRAL PLIF POSTERIOR LUMBAR INTERBODY FUSION (PLIF) CEMENT INJECTION INTO 6 SCREWS THERAPY FOR L5 COMPRESSION FRACTURE, NEUROLOGICAL SYMPTOMS PRESENT, L4-S (L6) 2 INTERVERTEBRAL PLIF. IT WAS REPORTED THAT AFTER L4 LEFT CEMENT INJECTION, THE DELIVERY TIP REMAINED. IT WAS REMOVED USING A KOCHER, BUT CEMENT REMAINED IN THE CROWN PART OF THE SCREW. CEMENT LEAKAGE TO THE CROWN PART WAS REPORTED. IT WAS DETERMINED THAT THE SCREW HEAD'S MOVEMENT WAS POOR AND IT WOULD BE A HINDRANCE TO ROD INSTALLATION; THE REMAINING CEMENT WAS REMOVED WITH A KOCHER AND THE SURGERY WAS CONTINUED. THERE WAS NO ISSUE WITH THE BONE CEMENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

H6: UPDATED DEVICE CODES (FDD/ANNEX A) CODE. 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.