BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS HFD100 HEAD FIXATION DEVICE

    MDR report key: 21229000 · Received January 24, 2025

    Report

    Report Number
    21229000
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 7, 2025
    Report Date
    January 9, 2025
    Manufacturer
    DEERFIELD IMAGING, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SCREW BROKE AS IT WAS BEING TIGHTENED. MANUFACTURER RESPONSE FOR MR ADAPTOR SCREW, IMRIS (PER SITE REPORTER). THEY ARE FILING AN INCIDENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669175 IMRIS HFD100 HEAD FIXATION DEVICE HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL DEERFIELD IMAGING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown