CD HORIZON® FENESTRATED SCREW 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. E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. 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 TH10-L4 FIXATION SPINAL THERAPY FOR DISH L2 FRACTURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POSTOPERATIVE FALL THAT REPORTEDLY LED TO LOOSENING OF THE IMPLANTED SCREW DUE TO IMPACT FROM THE FALL. THE CASE INVOLVED REOPERATION FOR EXTENSION DUE TO INSTABILITY OF FIXATION, WITH THE REPORTED COMPLICATION IDENTIFIED AS SCREW LOOSENING AND HEALTH HARM PRESENT. ADDITIONAL TREATMENT WAS PERFORMED, CONSISTING OF SCREW REPLACEMENT AND PELVIC REFIXATION, AND THE PATIENT WAS REPORTED AS RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SETSCREW HAS BEEN EXPLANTED IN ORDER TO ALLOW REINSTALLATION. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND NO HEALTH IMPACT.