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 L3/4/5 VERTEBRAL COLUMN RESECTION/ SPINE FUSION (VCR/PF) THERAPY FOR L4 RUPTURE FRACTURE. IT WAS REPORTED THAT CEMENT WAS INJECTED AFTER DEVICE PLACEMENT (WITH PROPER VISCOSITY ACHIEVED 15 MINUTES AFTER MIXING). THERE WAS SLIGHT LEAKAGE ON THE LEFT SIDE OF L5, CAUSING THE TIP TO ADHERE. ALTHOUGH THE ADHERED PORTION WAS REMOVED USING A CHISEL, SCREW LOOSENING WAS OBSERVED, LEADING TO A SIZE ADJUSTMENT. AFTERWARD, THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS A DELAY OF LEE THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO ALLEGATION AGAINST TIP.