BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYOCERA MEDICAL TECHNOLOGIES, INC.

    MDR report key: 12003346 · Received June 15, 2021

    Report

    Report Number
    3015398319-2021-00002
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 1, 2021
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    OVE
    PMA / PMN Number
    K153250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SURGERY WAS COMPLETED ON (B)(6) 2021. THE COMPLAINT WAS REPORTED TO KMTI BY THE AUSTRALIAN DISTRIBUTOR AFTER A FOLLOW-UP EXAMINATION (<24HR POST-SURGERY). THE PATIENT WAS ASYMPTOMATIC, BUT AN X-RAY REVEALED THE COVER PLATE WAS NOT ATTACHED TO THE FRONT OF THE CAGE. THE EXPLANATION PROVIDED BY THE DISTRIBUTOR STATES "IT WAS DIFFICULT TO GET THE RIGHT SCREW ANGLES BUT IN THE END THE SURGEON WAS HAPPY. HE GOT THE LOCKING PLATE ON AND TESTED WITH A NERVE HOOK BUT IT HAS BECOME DISLODGED IN THE POST OP X RAYS THE FOLLOWING DAY." THE SURGEON MADE THE DECISION TO REMOVE THE COVER PLATE, AND NOT REPLACE, THE DAY AFTER THE INITIAL SURGERY. FROM THE POST-OP X-RAY IMAGE, THE FOLLOWING INFORMATION CAN BE GATHERED: SURGERY WAS PERFORMED ADJACENT TO PREVIOUS FUSION LEVELS. THE CONSTRUCT WAS ORIENTED 2UP/1 DOWN (THE TWO OUTBOARD SCREWS WERE INSERTED INTO THE SUPERIOR VERTEBRA WHILE THE CENTER SCREW WAS INSERTED INTO THE INFERIOR VERTEBRA). THE COVER PLATE HAS DISLODGED FROM THE CAGE. THE COVER PLATE IS IN THE OVERLOCKED POSITION. THE MOST LIKELY CAUSE FOR THE FAILURE IS THE COVER PLATE NOT BEING FULLY LOCKED. THE CUSTOMER NARRATIVE STATES THAT THE SURGEON HAD DIFFICULTY LOCKING THE COVER PLATE. TO PROPERLY LOCK, THE CENTER POST OF THE COVER PLATE MUST BE ROTATED 90°. WHEN THIS HAPPENS THE FOOT OF THE CENTER POST IS SUPPOSED TO BE CAPTURED IN A SLOT, PREVENTING THE COVER PLATE FROM COMING OFF. IT IS BELIEVED THAT WHEN THE FOOT WAS ROTATED, IT WAS BLOCKED FROM ENTERING THE SLOT BY THE CENTER SCREW AND DID NOT LOCK. BECAUSE THE COVER PLATE WAS NOT LOCKED, THE SURGEON CONTINUED TO ROTATE UNTIL THE COVER PLATE FOOT WAS 180° FROM THE STARTING POSITION. IN THIS POSITION THE COVER PLATE WILL LAY FLAT. THE CUSTOMER NARRATIVE STATES THAT THE SURGEON USED A NERVE HOOK TO PULL ON THE COVER PLATE AT THE TIME OF SURGERY AND IT DID NOT COME OFF. THIS IS POSSIBLE AS TWO OF THE THREE LOCKING POINTS (TWO "EARS") WERE PROPERLY INSERTED INTO THE CAGE AND HOLD THE COVER PLATE ENOUGH TO RESIST SOME MOVEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2021 KMTI WAS NOTIFIED BY A DISTRIBUTOR THAT A LOCKING COVER PLATE HAD BECOME DISLODGED POST SURGERY. THIS WAS DISCOVERED IN THE POST-OP X-RAYS THE DAY AFTER SURGERY. THE SURGEON WAS PLANNING TO REVISE THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895719 KYOCERA MEDICAL TECHNOLOGIES, INC. SA CERVICAL COVER PLATE, NITINOL GEN 2 OVE KYOCERA MEDICAL TECHNOLOGIES, INC. 13167-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention