INNOVASIS AXHA STAND ALONE ALIF

Additional Manufacturer Narrative

ON APRIL 29 2020 DOCTOR CONTACTED INNOVASIS REPRESENTATIVE AFTER HE LEARNED THAT AN ADVERSE EVENT REPORT WAS APPROPRIATE FOR THIS CASE, BUT HE DID NOT BELIEVE THAT THE BROKEN VERTEBRA WAS CAUSED BY THE STAND ALONE ALIF DEVICES IMPLANTED NOR CONTRIBUTED BY THEM; RATHER HE BELIEVES IT WAS DUE TO AN AGGRESSIVE CORRECTION COMBINED WITH OSTEOPENIC BONE THAT WOULD HAVE BENEFITTED (IN HINDSIGHT) FROM ADDITIONAL HARDWARE ABOVE THE LUMBAR REGION. BECAUSE THE INCIDENT OCCURRED A MONTH AFTER SURGERY AND DID NOT IMPLICATE THE IMPLANTS, NO REPORT WAS FILED AT THAT TIME BY INNOVASIS UNDER THE ASSUMPTION THAT THE REPORT SHOULD HAVE COME FROM THE FACILITY. HOWEVER, THE DOCTOR CONTACTED INNOVASIS IN LATE JUNE AND REQUESTED THAT INNOVASIS FILE THE MDR. NOTE: THE COMPANY WAS HAVING ISSUES WITH ESG GATEWAY AND THEN THE ACK3 NOTIFICATION OF FAILURE DUE TO CHARACTER LIMIT WAS NOT NOTICED UNTIL 8/28/2020.

Description of Event or Problem

THE PATIENT HAD TWO PREVIOUS SURGERIES (B)(6) PRIOR TO THE INITIAL SURGERY PERFORMED ON (B)(6) (OSTEOMY) AND (B)(6) (CAGES) 2020. PATIENT PRESENTED WITH FLAT BACK SYNDROME AND PERSISTENT PAIN. SURGEON IMPLANTED 3 LORDOTIC IBF CAGES TO RESTORE LORDOSIS AND RELIEVE PRESSURE ON NERVES. ON (B)(6) 2020 THE SURGEON WAS NOTIFIED OF A FRACTURE TO THE L5 VERTEBRAE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 (DELAY DUE TO COVID-19). DR. HAS REPORTED THAT IN SUMMARY, THE FRACTURE TO THE VERTEBRAE WAS A RESULT OF COMPRESSION CAUSED BY INSUFFICIENT SPINAL SUPPORT IN THE PREVIOUS SURGICAL CONSTRUCTS AND PATIENT IS DOING WELL AS OF EARLY (B)(6) 2020.