BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    KYOCERA MEDICAL TECHNOLOGIES, INC.

    MDR report key: 13056886 · Received December 21, 2021

    Report

    Report Number
    3015398319-2021-00004
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 21, 2021
    Report Date
    December 20, 2021
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    OVD
    UDI-DI
    00841523100019
    PMA / PMN Number
    K131122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL SURGERY WAS COMPLETED ON (B)(6) 2021. THE COMPLAINT WAS REPORTED TO KMTI ON 11/21/2021 AND IT INVOLVED A TESERA SA ALIF SYSTEM IMPLANT (COVER PLATE). AT 3-WEEKS POST-OP, IT WAS NOTICED THE IMPLANT COVER PLATE HAD DISENGAGED FROM THE IMPLANT INTERBODY CAGE, AND THE IMPLANT COVER PLATE CENTER-POST FEATURE WAS NOW SLIGHTLY PROUD OF THE FRONT OF THE COVER PLATE ASSEMBLY. THE SUPERIOR AND INFERIOR INTERBODY FUSION COVER PLATES DID NOT SHOW ANY EVIDENCE OF DISSOCIATION; ONLY THE MID-LEVEL INTERBODY CAGE HAD A DISSOCIATED COVER PLATE AS SHOWN IN THE X-RAY AT 3-WEEKS AND 6-WEEKS POST-OP. PERFORMING A 3-LEVEL SA ANTERIOR LUMBAR INTERBODY FUSION IS NOT INDICATED IN THE SYSTEM IFU. PATIENT HARM HAS NOT BEEN REPORTED. UP TO DATE, IT HAS BEEN CONFIRMED, NO REVISION SURGERY HAS BEEN PLANNED OR SCHEDULED. IT IS UNKNOWN WHICH COVER PLATE LISTED BELOW WAS THE ONE THAT DISSOCIATED. HOWEVER, ALL 3 LOT #'S WERE INVESTIGATED. ALL COVER PLATES USED DURING THIS SURGERY: 1028-003-001, 13159-1. 1028-003-001, 13159-2. 1028-003-001, 13159-3. THE EXACT CAUSE OF THE COVERPLATE MALFUNCTION IS UNKNOWN AS THE IN-VIVO X-RAYS, CUSTOMER NARRATIVE AND DEVICE HISTORY RECORDS DO NOT PROVIDE ENOUGH EVIDENCE TO IDENTIFY AN EXACT CAUSE. THE IMPLANTS WERE NOT RETURNED FOR REVIEW, AS THEY REMAIN IMPLANTED, SO KMTI WAS UNABLE TO DETERMINE IF THE COMPLAINT WAS DUE TO DAMAGE, MANUFACTURING ERROR, A DESIGN ERROR OR SURGEON ERROR DURING IMPLANTATION. DAMAGE OF THE COVERPLATE OR CAGE COULD LEAD TO DISASSEMBLY, BUT POST-OP, 3 -WEEK AND 6-WEEK FOLLOW-UP X-RAYS DO NOT SHOW ANY DAMAGE TO IMPLANT COMPONENTS. A MANUFACTURING ERROR RESULTING IN IMPLANTS WHICH FAIL TO MEET SPECIFICATION COULD LEAD TO DISASSEMBLY, BUT THE DHRS FOR THE IMPLANTS IN THE COMPLAINT, ALL MEET SPECIFICATIONS NEEDED TO FULLY LOCK THE COVERPLATE. THE TOLERANCE STACK-UP ANALYSIS FOR THESE IMPLANTS WAS REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION AND REVEALED NO DESIGN ERRORS. THE SURGEON NOT PROPERLY LOCKING THE COVERPLATE IS POSSIBLE BUT NOT CONCLUSIVE. THE IN-VIVO X-RAY APPEARS TO SHOW THE COVERPLATE NOT FULLY LOCKED, BUT THIS IS REFUTED BY CUSTOMER NARRATIVE AND HISTORY. SURGEON CUSTOMER IS A LONGTIME USER OF THE DEVICE, AND IS VERY FAMILIAR WITH HOW TO LOCK THE COVERPLATE, AND TYPICALLY VERIFIES PROPER LOCKING WITH A MANUAL CHECK AFTER LOCKING. IN ADDITION, THE COVERPLATE INCLUDES A VISUAL INDICATOR TO INFORM THE SURGEON WHEN PROPERLY LOCKED. AS THE PARTS WERE NEVER RETURNED FOR EVALUATION, A MOST PROBABLE CAUSE COULD NOT BE IDENTIFIED AT THIS TIME, BUT KMTI WILL CONTINUE TO MONITOR FOR ANY FURTHER INFORMATION AND UPDATE THIS INVESTIGATION RESULT AS NEEDED.

    Description of Event or Problem · 0

    THE COVER PLATE HAS DISENGAGED FROM THE CAGE AS SEEN IN 3 AND 6 WEEKS POST-OP IMAGING. THE CENTER POST OF THE COVER PLATE IS SLIGHTLY PROUD OF THE FRONT OF THE COVER PLATE FOR THE ASSEMBLY. NO REVISION CASE HAS BEEN SCHEDULED AND NO HARM HAS BEEN CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949541 KYOCERA MEDICAL TECHNOLOGIES, INC. LOCKING COVER PLATE OVD KYOCERA MEDICAL TECHNOLOGIES, INC. Tesera 13159-1 00841523100019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown