CD HORIZON® SOLERA® SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXA TION FROM T12 TO L4 FOR AN L2 COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING NAVIGATION-GUIDED INSERTION OF THE LEFT PERCUTANEOUS PEDICLE SCREW AT T12, SCREW DEVIATION OCCURRED. THE REPORTED CAUSE WAS DISPLACEMENT OF THE REFERENCE PLACED ON THE L4 SPINOUS PROCESS. NAVIGATION WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED UNDER FLUOROSCOPY. NO TREATMENT OR ADDITIONAL SURGERY WAS REPORTED. NO DEVICE DAMAGE WAS REPORTED, AND THE IMPLANTED DEVICE REMAINED IN SERVICE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

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.