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 EXTENSION DUE TO PROXIMAL JUNCTIONAL FAILURE FOR OSTEOPOROTIC VERTEBRAL FRACTURE. IT WAS REPORTED THAT AFTER INITIAL FIXATION FROM T11 TO L3, THE CONSTRUCT WAS EXTENDED UP TO T8 DUE TO PROXIMAL JUNCTIONAL FAILURE, RESULTING IN THE IMPLANT SPANNING LEVELS T8 TO L3. REFIXATION AT T8-T9 WAS PERFORMED USING CAPS (CAP SCREWS OR CONNECTORS). IT RESULTED IN DECREASED MOTOR FUNCTION OF THE LOWER LIMBS LEADING TO DISABILITY TO THE PATIENT. PATIENT DID NOT ACHIEVE BONE FUSION, AS THE PERIOD HAS BEEN SHORT. THERE WAS NO MALFUNCTION AGAINST THE PRODUCT ITSELF. BUT THERE IS A POSSIBILITY THAT THE PROXIMAL JUNCTIONAL FAILURE (PJF) IS ATTRIBUTABLE TO THE MEDTRONIC DEVICE USED IN THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.