BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYOCERA MEDICAL TECHNOLOGIES, INC

    MDR report key: 19056126 · Received April 5, 2024

    Report

    Report Number
    3015398319-2024-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    November 24, 2023
    Report Date
    March 7, 2024
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    OVE
    UDI-DI
    00841523117949
    PMA / PMN Number
    K153250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, AN EXPIRED IMPLANT WAS INADVERTENTLY IMPLANTED INTO A PATIENT ON (B)(6) 2023, IN AUSTRALIA. 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 PRODUCT QUALITY ISSUES WITH RESPECT TO DESIGN, MANUFACTURING, OR LABELING. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE REVISED/RETURNED. THIS ISSUE WAS ADDED TO AN INTERNAL CAPA TO ADDRESS EXPIRED OR EXPIRING INVENTORY CONSIGNED WITH INDEPENDENT SALES REPRESENTATIVES. SINCE THIS PRODUCT WAS IMPLANTED, KMTI LOCATED 10 PACKAGED IMPLANTS FROM A SIMILAR LOT THAT HAS THE SAME PACKAGING CONFIGURATION AND THAT HAD EXPIRED ON 01/20/2022. THE PACKAGING ON THESE 10 IMPLANTS WAS TESTED AT PRO-TECH DESIGN AND MFG (SANTA FE SPRINGS, CA) TO ASSESS WHETHER THE PACKAGES HAD RETAINED SUFFICIENT PACKAGE SEAL STRENGTH (N=10) AND PACKAGING SEAL INTEGRITY (BUBBLE EMISSION, N=10) TEST RESULTS WERE ACCEPTABLE FOR BOTH TESTS (TEST NAME JOB 31130-01 AND TR-23-045-01). THE TESTING SHOWED EXPIRED IMPLANTS MOST LIKELY RETAINED SUFFICIENT SEAL STRENGTH AND SEAL INTEGRITY AFTER BEING EXPIRED FOR MORE THAN 20 MONTHS. 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 SEPTEMBER 6,2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104414 KYOCERA MEDICAL TECHNOLOGIES, INC TESERA SCREW, SELF DRILLING 4.0 X 12 MM OVE KYOCERA MEDICAL TECHNOLOGIES, INC. 11386-3 00841523117949

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male