CD HORIZON® SPINAL SYSTEM

Additional Manufacturer Narrative

E1: INITIAL REPORTER DETAILS ARE UNKNOWN D1, D.4. PRODUCT IDENTIFIERS ARE UNKNOWN. G2: COUNTRY OF ORIGIN IS JAPAN G4. PMA / 510(K) #- UNKNOWN AS PRODUCT IDENTIFIERS ARE 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR SPINAL CANAL STENOSIS AT L4/5. IT WAS REPORTED THAT THE LOOSENING OF THE SCREW HAVE CAUSED THE CAGE TO BACKOUT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO IN-PATIENT HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR ADDITIONAL/REVISION SURGERY PERFORMED. THE THERAPY WAS TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION). THE SCREWS WERE LOOSENING.