CD HORIZON® SPINAL SYSTEM

Additional Manufacturer Narrative

G4: THE DEVICE P/N 1556300500 IS SIMILAR TO THE DEVICE MANUFACTURED IN US P/N 1556000500. HENCE, MENTIONED 510K LICENSE NUMBER K111942 IS OF P/N 1556000500. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS. 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 POSTERIOR SPINAL FUSION T9¿SAI FIXATION DUE TO ADULT SPINAL DEFORMITY. IT WAS REPORTED THAT THE LEFT SAISCREW BACKED OUT, THE ROD BECAME DETACHED, AND THE SET SCREW DISLODGED. A ROD FRACTURE WAS ALSO OBSERVED AT LEFT L3/4. THE SCREW HAD GRADUALLY BACKED OUT STARTING AROUND THE YEAR FOLLOWING THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED ON JUNE 8 TO EXPLANT THE PRODUCTS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.