GRAFTON DBM

Additional Manufacturer Narrative

B2: OTHER - NERVE DAMAGE. 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 VIA A MANUFACTURER REPRESENTATIVE FROM PATIENT WHO WAS IMPLANTED WITH GRAFTON. IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH REPORTED GRAFTON DURING CERVICAL SPINE SURGERY ON (B)(6) 2020. DURING THIS SURGERY, THE GRAFTON BONE GRAFT PRODUCT WAS IMPLANTED IN PATIENT'S CERVICAL SPINE. PATIENT ALLEGED THAT USING GRAFTON IN THE CERVICAL SPINE WAS A DANGEROUS "OFF-LABEL" USE. FOLLOWING THE SURGERY AND IMPLANTATION OF GRAFTON, PATIENT SUFFERED SEVERE AND DEBILITATING INJURIES, INCLUDING BUT NOT LIMITED TO, UNCONTROLLED ECTOPIC BONE GROWTH, NERVE DAMAGE, NEED FOR ADDITIONAL SURGERIES, DAILY DEBILITATING NERVE PAIN, DECREASE IN MOBILITY AND MOVEMENTS OF THE NECK.