CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Additional Manufacturer Narrative

B3: EVENT DATE IS UNKNOWN. D4: LOT# IS UNKNOWN. E1: INITIAL REPORTER DETAILS ARE UNKNOWN. G2: COUNTRY OF ORIGIN IS JAPAN. 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 POSTERIOR FIXAT ION SPINAL THERAPY FOR REPLACEMENT OF L3, L4, S1 SCREWS AND EXTENSION OF FIXATION TO S2AI. INITIAL SURGERY HAPPENED ON (B)(6) 2025 FOR A PATIENT HAVING POSTERIOR FIXATION FROM L3/S1 FOR L3 COMPRESSION FRACTURE AND L5 BURST FRACTURE. FNSMAS WAS USED FOR L3,S1, AND SAS WAS USED FOR L4. REVISION SURGERY HAPPENED ON (B)(6) 2025. IT WAS REPORTED THAT THE CEMENT FROM S1 HAS LEAKED INTO THE SPINAL CANAL (BUT THERE IS NO PAIN ORIGINATING FROM THAT AREA). ADDITIONALLY, THE SCREW IN S1 HAS CUT OUT CAUDALLY. CEMENT REMAINS ON THE CRANIAL SIDE OF S1. IT IS PRESUMED THAT EVEN MORE STRESS WAS PLACED ON S1 BECAUSE THE PATIENT REFUSED TO WEAR A CORSET AFTER THE PREVIOUS SURGERY. THERE WAS UNKNOWN PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.