BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    KYOCERA MEDICAL TECHNOLOGIES, INC.

    MDR report key: 13006482 · Received December 14, 2021

    Report

    Report Number
    3015398319-2021-00003
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 13, 2021
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    ODP
    UDI-DI
    00841523118045
    PMA / PMN Number
    K153250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, AN EXPIRED CERVICAL SCREW WAS INADVERTENTLY IMPLANTED INTO THE PATIENT AND IMMEDIATELY TAKEN OUT. THERE WAS NO REPORTED PATIENT INJURY/INFECTION. 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. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING, OR LABELING. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT RELEASED FOR DISTRIBUTION IN (B)(6) 2016. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. EXPIRED IMPLANT WAS DISCARDED AND NOT RETURNED.

    Description of Event or Problem · 0

    AN EXPIRED SCREW WAS USED DURING PROCEDURE. SCREW EXPIRED (B)(6) 2021. SCREW WAS IMMEDIATELY TAKEN OUT AND REPLACED WITH AN UNEXPIRED SCREW. NOTE: NO REVISION SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890195 KYOCERA MEDICAL TECHNOLOGIES, INC. SA CERVICAL SCREW 4.0MM SELF TAPPING, 12MM ODP KYOCERA MEDICAL TECHNOLOGIES, INC. S 150 3683-3 00841523118045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown