BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYOCERA MEDICAL TECHNOLOGIES, INC.

    MDR report key: 17187858 · Received June 22, 2023

    Report

    Report Number
    3015398319-2023-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MAX
    UDI-DI
    00841523134168
    PMA / PMN Number
    K212070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, AN EXPIRED IMPLANT WAS INADVERTENTLY IMPLANTED INTO THE PATIENT. THERE HAS BEEN NO REPORTED PATIENT INJURY/INFECTION TO DATE. NO REVISION SURGERY WAS REPORTED. THE EXPIRATION DATE IS LOCATED ON MULTIPLE LAYERS OF THE PACKAGING. THIS EVENT IS CONFIRMED AS A USER RELATED ERROR WITH NO MALFUNCTION OF THE DEVICE. A REVIEW OF MANUFACTURING RECORDS CONFIRMS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING, OR LABELING. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE REVISED/RETURNED. AN INTERNAL CAPA WAS OPENED TO ADDRESS EXPIRED OR EXPIRING INVENTORY CONSIGNED WITH INDEPENDENT SALES REPRESENTATIVES. KMTI WILL TEST EXPIRED PACKAGES FROM THE SAME OR SIMILAR LOTS TO VERIFY IF THE PACKAGE RETAINED SUFFICIENT SEAL STRENGTH AND SEAL INTEGRITY POST EXPIRATION. BASED ON PREVIOUS TESTING PERFORMED BY KMTI ON OTHER EXPIRED PACKAGE(S) IT IS MOST LIKELY THE EXPIRED PACKAGE(S) TESTING WILL SHOW THE PACKAGE(S) DID RETAIN SUFFICIENT SEAL STRENGTH AND SEAL INTEGRITY FOR AT LEAST ONE MONTH POST EXPIRATION. THE SEAL TESTING WILL BE PERFORMED WITHIN THE NEXT THIRTY DAYS. RESULTS, WHEN THEY ARE AVAILABLE, WILL BE RECORDED WITHIN THE KMTI INTERNAL CAPA PROCESS. IF THE RESULTS SHOW SUFFICIENT SEAL STRENGTH AND SEAL INTEGRITY, NO SUPPLEMENTAL MDR WILL BE SUBMITTED. IF THE RESULTS SHOW COMPROMISED SEAL STRENGTH AND SEAL INTEGRITY, A SUPPLEMENTAL MDR WILL BE SUBMITTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED BY THE HEALTHCARE PROVIDER, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AN EXPIRED IMPLANT WAS USED IN SURGERY ON (B)(6) 2023. THE IMPLANT EXPIRED ON (B)(6) 2023. DURING THE PROCEDURE, THE SALES REPRESENTATIVE NOTIFIED THE SURGEON OF THE EXPIRED IMPLANT; HOWEVER, THE SURGEON WAS COMFORTABLE WITH LEAVING THE IMPLANT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447660 KYOCERA MEDICAL TECHNOLOGIES, INC. TESERA ST LUMBAR INTERBODY IMPLANT MAX KYOCERA MEDICAL TECHNOLOGIES, INC. S 141 11183-14 00841523134168

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male