UNKNOWN

Additional Manufacturer Narrative

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 HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT AFTER FALL, PATIENT HAS LOOSENING SCREWS ALONG L5 ALONG PEDICLE FOUND BY CT. PATIENT REPORTED LOW BACK PAIN. SITE RELATED ASSESSMENT UNLIKELY TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, PROBABLE TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TLIF GRAFTING MATERIAL AND TLIF PROCEDURE. SPONSOR ASSESESS AS UNRELATED TO TLIF PROCEDURE, GRAFTING MATERIAL AND FUSION DEVICE AND CAUSALLY RELATED TO FIXATION SYSTEM MEDICAL HISTORY: HYPERTENSION.