BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVASIS AXHA STAND ALONE ALIF

    MDR report key: 10474904 · Received August 31, 2020

    Report

    Report Number
    3004719693-2020-00001
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    March 13, 2020
    Report Date
    July 8, 2020
    Manufacturer
    INNOVASIS, INC
    Product Code
    OVD
    PMA / PMN Number
    K162236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939382 INNOVASIS AXHA STAND ALONE ALIF STAND ALONE ALIF IBF DEVICE OVD INNOVASIS, INC AXHA STAND ALONE IBF 16X36MM 20 DEGREES 1701

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention