BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXHA PEEK IBF SYSTEM

    MDR report key: 11436174 · Received March 8, 2021

    Report

    Report Number
    3004719693-2021-00001
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    November 19, 2020
    Report Date
    March 1, 2021
    Manufacturer
    INNOVASIS, INC
    Product Code
    MAX
    UDI-DI
    M711AX1430141
    PMA / PMN Number
    K162236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    THE AX143014 IS AN IMPLANTED PART OF THE AXHA STAND ALONE ALIF SYSTEM. THE AXHA STANDALONE ALIF SYSTEM IS AN INTERVERTEBRAL BODY FUSION DEVICE FOR USE IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO CONTIGUOUS LEVELS OF THE LUMBAR SPINE. SURGEONS USING THIS SYSTEM SELECT AN APPROPRIATE SIZE IMPLANT USING TRIALS TO DETERMINE BEST FIT. ONCE SIZE IS SELECTED, THE IMPLANT IS INSERTED AND SECURED IN PLACE USING SCREWS. HYPERLORDOTIC IMPLANTS THOSE WITH A LORDOTIC ANGLE GREATER THAN OR EQUAL TO 20 ARE INDICATED FOR USE WITH A SUPPLEMENTAL SPINAL FIXATION SYSTEM. THE SURGICAL TECHNIQUE GUIDE STRESSES IMPORTANCE OF PATIENT SELECTION, IMPLANT SIZE SELECTION, AND PATIENT COMPLIANCE WITH POSTOPERATIVE CARE INSTRUCTIONS IN ORDER TO INCREASE THE LIKELIHOOD OF FAVORABLE SURGICAL OUTCOMES. SUMMARY DAMAGE TO THE IMPLANT NONE OBSERVED, PER SURGEON THE IMPLANT FUNCTIONED AS EXPECTED AND SHOWED NO SIGNS OF DAMAGE OR DEFECT. PATIENT IMPACT FRACTURE OF SUPERIOR PORTION OF L5, BACK PAIN. REVISION SURGERY DID NOT REVERSE SETTLING, BUT ALLEVIATED BACK PAIN AND PATIENT IS REPORTED AS DOING WELL. NO DIFFICULTIES DURING SURGERY, VERY SMOOTH SURGERY, NO ISSUES MAKING A SIZE CHOICE AND SURGEON WAS VERY SATISFIED WITH OUTCOME PRIOR TO SUBSEQUENT ISSUES. PATIENT HEALTH/SELECTION FEMALE, EARLY 60S, BONE DENSITY SCAN SHOWED REASONABLY GOOD BONE, HOWEVER THERE WAS SOME OSTEOPENIA.

    Description of Event or Problem · 1

    ON (B)(6), 2021. INNOVASIS RECEIVED A PHONE CALL FROM DISTRIBUTOR (B)(4). INFORMING THAT DR. (B)(6) USED AN AX CAGE SEVERAL WEEKS AGO AND THE PATIENT HAS A VERTEBRAL BODY FRACTURE ON L5. IT WAS ALSO NOTED THAT NOTHING WENT WRONG WITH CAGE OR SYSTEM ITSELF. TIMELINE (B)(6) 2020 PATIENT SURGERY FOR BACK PAIN, L4 5-L4 5S1, LACK OF LORDOSIS. USED 2 CAGES WITH HIGH DEGREE OF LORDOSIS 14MM 14 CAGE AT L5S1, 16MM 20 AT L4-L5. PATIENT DEVELOPED OGILVIE SYNDROME BLOATING GI ISSUES POST OP ILEUS, REQUIRED MEDICAL TREATMENT 1 WEEK HOSPITALIZATION WHICH WENT WELL . CT SCAN FOR ILEUS SHOWS A LITTLE SETTLING OF THE IMPLANT. NOTE ILEUS NOT SPECIFIC TO IMPLANT DEVICE; RELATED TO ANY ABDOMINAL PROCEDURE. (B)(6) 2020, 2 WEEKS AFTER SURGERY SEVERE BACK PAIN, CT SCAN SHOWS A LOT MORE SETTLING SUBSIDENCE. (B)(6) 2020 REVISION SURGERY PERFORMED, POSTERIOR FIXATION. ONCE PEDICLE SCREWS WERE IMPLANTED THE SETTLING STOPPED. THE IMPLANT HAS MAXED OUT ON SUBSIDENCE, CAGE ALL THE WAY INTO THE VERTEBRAL BODY. REVISION HELPED PATIENT'S BACK PAIN AND SHE IS NOW DOING VERY WELL (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330833 AXHA PEEK IBF SYSTEM INTERBODY FUSION DEVICE MAX INNOVASIS, INC AX,14X30X14DEG 1901 M711AX1430141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R