BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN¿ SCREW, 5MM, BURR HOLE COVER

    MDR report key: 15765099 · Received November 9, 2022

    Report

    Report Number
    1627487-2022-06111
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    October 20, 2022
    Report Date
    August 20, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05414734403078
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EXPIRED BUTT HOLE CAP SCREW WAS REPORTED TO ABBOTT. THE ISSUE WAS NOTED WHILE REVIEWING PRODUCT PACKAGING AFTER THE OPERATION WAS COMPLETE. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT WITH THE UNINTENTIONAL USE OF EXPIRED PRODUCT. ADDITIONALLY, THE DEVICE HISTORY RECORD OF THE DEVICE WAS REVIEWED TO CONFIRM THAT ALL MANUFACTURING STEPS WERE COMPLETED AND THERE WERE NO NON-CONFORMANCES NOTED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ACTIONS HAVE BEEN TAKEN TO PREVENT REOCCURRENCE VIA CAPA 132510.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF THE DBS IMPLANT PROCEDURE IT WAS FOUND THAT AN EXPIRED GUARDIAN SCREW WAS OPENED BY THE CIRCULATOR AND IMPLANTED BY THE PHYSICIAN. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432830 GUARDIAN¿ SCREW, 5MM, BURR HOLE COVER DBS BUR HOLE COVER SCREW MHY ABBOTT MEDICAL 6015 7616593 05414734403078

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DBS BURR HOLE CAP (2)| DBS LEAD (2)