BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVIS

    MDR report key: 8299392 · Received February 1, 2019

    Report

    Report Number
    3007932279-2019-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 1, 2019
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    OVD
    UDI-DI
    00841523100675
    PMA / PMN Number
    K180502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATING SURGEON INFORMED RENOVIS CUSTOMER SERVICE OF A PRODUCT COMPLAINT ON (B)(6) 2019. THE IMPLANTS WERE REPORTED TO RENOVIS BECAUSE, PER THE COMPLAINT, "THE SURGEON NOTICED THAT THE ALIF CAGE, IMPLANTED IN 2015, HAD FRACTURED." THE CAGE WAS IMPLANTED ON (B)(6) 2015 AND FOLLOW-UP X-RAYS TAKEN AT THE 1-YEAR FOLLOW-UP SHOW THE CAGE IS INTACT AS OF THAT DATE. THE PATIENT COMPLAINED OF SEVERE LOWER BACK PAIN STARTING APPROXIMATELY TWO WEEKS BEFORE AN OFFICE VISIT ON (B)(6) 2018. DURING THIS VISIT, X-RAYS WERE TAKEN AND SHOW THE CAGE HAS FRACTURED. X-RAYS TAKEN AT 1-YEAR POST-OP DO NOT SHOW ANY SIGNS OF CAGE FRACTURE. IN ADDITION, THERE APPEARS TO BE FUSION AT THE ENDPLATES OF THE CAGE BUT LITTLE BONY MASS VISIBLE THROUGH THE SIDE WINDOWS OF THE CAGE. X-RAYS TAKEN AT 3-YEARS POST-OP SHOW THE CAGE FRACTURED IN HALF. THE FRACTURE LOCATIONS ARE THE ANTERIOR SUPERIOR AND POSTERIOR INFERIOR CORNERS OF THE LATERAL GRAFT VISUALIZATION WINDOWS. BASED ON THE 3-YEAR POST-OP X-RAY, THE SCREWS AND COVER PLATE SHOW NO SIGNS OF DAMAGE OR LOOSENING AND ARE THEREFORE EXCLUDED FROM THIS COMPLAINT INVESTIGATION. THE DHR FOR THE FRACTURED CAGE REVEALED NO NON-CONFORMANCES. IN BOTH THE 1- AND 3-YEAR POST-OP X-RAYS, THERE IS LITTLE EVIDENCE OF BONY FUSION IN THE GRAFT CHAMBER OF THE CAGE. WITH INTERBODY FUSION CAGES, THE LONG-TERM GOAL IS BONY FUSION OF THE ADJACENT VERTEBRAE THROUGH THE GRAFT CHAMBER OF THE CAGE. AS STATED IN THE POTENTIAL RISKS SECTION OF IFU FOR THE S 128 ALIF SYSTEM (IFU 4128-005) "METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND ACTIVITY LEVELS EQUAL TO THOSE PLACED ON NORMAL HEALTHY BONE. NO IMPLANT CAN BE EXPECTED TO WITHSTAND INDEFINITELY THE UNSUPPORTED STRESS OF FULL WEIGHT BEARING." BASED ON THE PATIENT REPORTING SEVERE PAIN TWO WEEKS BEFORE THE 3-YEAR FOLLOW UP, THERE IS EVIDENCE TO SUGGEST THAT THE CAGE DID NOT FRACTURE UNTIL 3-YEAR POST-OP. NO INTERBODY DEVICE IS EXPECTED TO WITHSTAND FULL WEIGHT BEARING FOR THIS PERIOD. RENOVIS WILL CONTINUE TO MONITOR FOR COMPLAINTS AND TAKE ADDITIONAL ACTION IF DEEMED NECESSARY. IF/WHEN RENOVIS IS INFORMED OF A REVISION SURGERY, THIS COMPLAINT INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    WHILE DISCUSSING THE CURRENT ALIF DESIGN WITH A SURGEON, THE SURGEON STATED THAT A PREVIOUS ALIF IMPLANT PATIENT HAD COMPLAINED OF PAIN IN (B)(6) 2018. UPON REVIEW OF A CURRENT X-RAY, THE SURGEON NOTICED THAT THE ALIF CAGE, IMPLANTED IN 2015, HAD FRACTURED. POST OP X-RAYS 1 YEAR POST-OP (2016) SHOWED THE CAGE STILL INTACT. THE PATIENT WAS DOING WELL UNTIL ABOUT A YEAR AGO. THE PATIENT STARTED EXPERIENCING SEVERE BACK PAIN ABOUT 2 WEEKS PRIOR TO THEIR VISIT ON (B)(6) 2018. THE CAGE FAILURE OCCURRED SOMETIME BETWEEN 2016 AND 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91837 RENOVIS TI-6AL-4V ALIF IMPLANT 38 X 30, 13MM 12° LORDOSIS OVD RENOVIS SURGICAL TECHNOLOGIES 2148-27 00841523100675

    Patients

    Seq Age Sex Outcome Treatment
    1