CD HORIZON® BALLAST¿ SPINAL SYSTEM

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 REAR FIXATION DUE TO LATERAL CANAL STENOSIS. DURING POSTERIOR FIXATION AT L3-SAI, AN ABNORMAL SLIPPERY SENSATION WAS ENCOUNTERED WHILE USING THE BALLAST SYSTEM TO SECURE A SET SCREW. THE SET SCREW WAS REMOVED, AND THREAD DAMAGE WAS OBSERVED. FRAGMENTS WERE COLLECTED, AND NO FRAGMENTS REMAINED IN THE PATIENT. A NEW SET SCREW WAS THEN FASTENED, AND THREAD CUTTING/RE-ENGAGEMENT WAS PERFORMED. SLIGHT PROTRUSION WAS NOTED ON THE REAR SIDE OF THE REPLACEMENT SET SCREW; HOWEVER, THE PROTRUSION WAS CONSIDERED MINIMAL, THREAD ENGAGEMENT WAS JUDGED ACCEPTABLE, AND CORRECT TORQUE WAS CONSIDERED ACHIEVED. THE WOUND WAS THEN CLOSED. THE IMPLANTED CONSTRUCT REMAINED IN SERVICE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.