BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR BOLT

    MDR report key: 11744439 · Received April 29, 2021

    Report

    Report Number
    11744439
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 8, 2021
    Manufacturer
    DIXI MEDICAL
    Product Code
    GZL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ANCHOR BOLT WAS BEING INSERTED INTO THE SKULL WHEN THE BOLT THREADS DIDN'T CATCH AND ADVANCED INTO THE PATIENTS BRAIN. PHYSICIAN WAS ABLE TO RETRIEVE THE ANCHOR BOLT AND AN INTRA-OPERATIVE CT WAS PERFORMED. CONCERN EXPRESSED THAT TRAINING AND EDUCATION WAS INADEQUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643201 ANCHOR BOLT ELECTRODE, DEPTH GZL DIXI MEDICAL 203868-26/20

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA Hospitalization| R