CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Additional Manufacturer Narrative

B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS ADDITIONAL SURGERY DUE TO DEVICE MALFUNCTION. G2: THE COUNTRY OF THE EVENT IS JAPAN 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 THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY FOR ADULT SPINAL DEFORMITY AND TH10-S2 LEVEL IMPLANT WAS PERFORMED. IT WAS REPORTED THAT THE SCREW LOOSENED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS PARTIAL REMOVAL WAS PERFORMED ON THE LEFT SIDE, TH10.11, L1.2 ADDITIONAL INFORMATION WAS RECEIVED ALL THE SCREWS WERE REMOVED FROM THE LEFT SIDE AND NO ADDITIONAL SURGERY IS NOT PLANNED AT THIS TIME.