CD HORIZON® SOLERA® SPINAL SYSTEM

Additional Manufacturer Narrative

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 THE MULTIPLE SOURCES (DISTRIBUTOR, HEALTHCARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE AND IDENTIFIED INTRAOPERATIVELY THAT ONE LOCKING SCREW HAD STRIPPED THREADS AND ONE SCREW HAD A STRIPPED SCREW HEAD DURING IMPLANTATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE/THERAPY INVOLVED WAS SPINAL DECOMPRESSION AND PERCUTANEOUS PEDICLE SCREW FIXATION. REPRESENTATIVE CONFIRMED THAT THE STRIPPED PRODUCTS QUANTITY WERE 5.