CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT L5-S1 USING FOUR VOYAGER FNS SCREWS AUGMENTED WITH BONE CEMENT AND AN INTERBODY CAGE, INTRAOPERATIVE ASSESSMENT AND IMMEDIATE POSTOPERATIVE X-RAYS CONFIRMED SATISFACTORY PLACEMENT AND CONSTRUCT STABILITY. DURING A ROUTINE FOLLOW-UP APPOINTMENT, A SUBSEQUENT X-RAY REVEALED LOOSENING AND BACKING OUT OF A SET SCREW. REVISION SURGERY WAS PERFORMED, DURING WHICH REMOVAL OF THE EXISTING INSTRUMENTATION REVEALED BONE CEMENT LEAKAGE UNDERNEATH THE TULIP HEAD OF THE AFFECTED SCREW. THE FUSION CONSTRUCT WAS EXTENDED FROM L4 TO S1, AND NEW INSTRUMENTATION INCLUDING A BALLAST SCREW WAS PLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRIMARY REPORTED EVENT INVOLVED THE LOOSENING AND BACKING OUT OF ONE (1) SPECIFIC SCREW, WHICH WAS DIRECTLY ASSOCIATED WITH THE OBSERVED CEMENT LEAKAGE UNDER ITS TULIP HEAD. UPON VISUAL INSPECTION DURING THE REVISION SURGERY, THE REMAINING THREE (3) SCREWS APPEARED INTACT AND WELL-FIXED, AND NO OVERT MALFUNCTION OR ALLEGATION IS REPORTED AGAINST THEM. THEY WERE REMOVED PROPHYLACTICALLY AS PART OF THE REVISION PROCEDURE TO EXTEND THE FUSION CONSTRUCT. DURING THE SURGERY, WHEN THE CEMENT WAS BEING INJECTED FOR PEDICLE SCREW AUGMENTATION, SOME CEMENT LEAKED UNDERNEATH THE TULIP HEAD OF ONE SCREW. THIS LEAKAGE OCCURRED DURING THE CEMENT DELIVERY PROCESS, AND AS A RESULT, THE TULIP HEAD COULD NOT PROPERLY SEAT TO SECURE THE ROD AND SET SCREW. THIS PREVENTED THE FINAL CONSTRUCT FROM BEING LOCKED ADEQUATELY, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE EVENTUAL LOOSENING AND BACKING OUT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REPRESENTATIVE WAS UNABLE TO CONFIRM THE SPECIFIC LOT NUMBER OF THE SCREW THAT BACKED OUT (H5958836 OR H5989465). AFTER EXTRACTION, THE SCREW WAS PLACED IN A SPECIMEN BOTTLE IN THE STERILE FIELD, AND HE DO NOT HAVE ACCESS TO THE LOT NUMBER INFORMATION. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CEMENT LEAK WAS NOT OBSERVED DURING THE INITIAL SURGERY ON (B)(6) 2025. IT WAS FIRST DISCOVERED DURING THE EXPLANT PROCEDURE ON (B)(6) 2025.

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.