CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. 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 A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR RUPTURE FRACTURE. IT WAS REPORTED THAT REMOVAL OPERATION PERFORMED AFTER BONE FUSION. THERE WAS A SCREW FRACTURE, SO IT WAS REMOVED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE SIZE WAS NOT CONFIRMED AT THE TIME OF REMOVAL, SO THE POSSIBLY APPLICABLE SIZE WERE REPORTED BASED ON RECORDS, AND ONE OF THE SCREWS WAS FOUND TO BE FRACTURED. SCREW REMOVAL WAS PERFORMED AFTER POSTOPERATIVE BONE FUSION. THE FRACTURE OCCURRED AT SOME POINT PRIOR TO REMOVAL.