CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Additional Manufacturer Narrative

E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. 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 A REVISION SPINAL SURGERY FOR AN L2 VERTEBRAL BODY COMPRESSION FRACTURE WITH PRIMARY OSTEOPOROSIS, CEMENT-AUGMENTED PEDICLE SCREW FIXATION WAS PERFORMED USING A MEDTRONIC VOYAGER FNS MAS SCREW SYSTEM. THE PATIENT HAD PREVIOUSLY UNDERGONE T11¿L1 FIXATION WITH CEMENT SCREWS FOR A T12 FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, CEMENT WAS OBSERVED LEAKING AROUND THE SCREW HEAD DURING INJECTION. THE SURGICAL INCISION WAS ENLARGED AND ATTEMPTS WERE MADE TO REMOVE THE LEAKED CEMENT USING SURGICAL INSTRUMENTS. RESIDUAL CEMENT REMAINED WITHIN THE SCREW HEAD, MAKING REMOVAL DIFFICULT AND REQUIRING MULTIPLE ATTEMPTS TO PLACE THE SET SCREW. THE ROD WAS EVENTUALLY SECURED AND THE PROCEDURE WAS COMPLETED. FOLLOWING FIXATION, THE SCREW WAS OBSERVED TO CUT OUT AND MIGRATE WITHIN THE VERTEBRAL BODY. REMOVAL OF THE SCREW WAS NOT POSSIBLE DUE TO HARDENED CEMENT, AND THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN PLACE AND MONITOR THE PATIENT. THE PROCEDURE WAS PROLONGED BY MORE THAN 60 MINUTES. APPROXIMATELY 1.8 CC OF CEMENT LEAKAGE WAS REPORTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE POSTOPERATIVE CT IMAGES WAS RECEIVED AND CONFIRMED, A SMALL AMOUNT OF CEMENT WAS SEEN LEAKING FROM THE TIP OF THE SCREW, WHICH SUGGESTS THAT IT WAS LIKELY DUE TO BACKFLOW. THE DOCTOR ALSO RECOGNIZED THE BACKFLOW WHEN REVIEWING THE IMAGES, BUT MENTIONED THAT THERE WAS A SLIGHT DISCREPANCY FROM A PROCEDURAL STANDPOINT. NORMALLY, IF THE PRESSURE INSIDE THE VERTEBRAL BODY IS HIGH, RESISTANCE WOULD BE FELT WHEN PUSHING THE DELIVERY DEVICE. HOWEVER, IN THIS CASE, THE DOCTOR REPORTED THAT SUCH RESISTANCE WAS NOT FELT. AFTER DISCUSSING THIS WITH MARKETING TEAM, IT WAS CONSIDERED POSSIBLE THAT THE BUTTON MAY HAVE BEEN INADVERTENTLY PRESSED WHILE ATTACHING THE OUTER SLEEVE, WHICH COULD HAVE CREATED A GAP THROUGH WHICH THE CEMENT LEAKED. THERE WERE NO MALFUNCTION FOR PLI#30 AND PLI#40. PLI#50 HAS BEEN CREATED FOR L2 VERTEBRAL FRACTURE THAT OCCURRED AFTER THE INITIAL SURGERY PERFORMED ON (B)(6) 2025. NO PRODUCT MALFUNCTION HAS BEEN REPORTED, AND SINCE THE DEVICE IS STILL IN USE, IT WILL NOT BE RETURNED.