BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTLELOC-P

    MDR report key: 15459841 · Received September 20, 2022

    Report

    Report Number
    3009790163-2022-00001
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    October 20, 2021
    Report Date
    November 3, 2021
    Manufacturer
    L&K BIOMED CO.,LTD.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ONE OF SCREW HOLE ON CERVICAL PLATE WAS NOT BIG ENOUGH FOR THE SCREW TO GO ALL THE WAY IN. THE SURGEON HAD TO USE ANOTHER PLATE AND PULL OUT 4 SCREWS AND PUT RESCUE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791858 CASTLELOC-P ANTERIOR CERVICAL PLATE SYSTEM LXH L&K BIOMED CO.,LTD. 20011619

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female