BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 14283814 · Received May 4, 2022

    Report

    Report Number
    3010326005-2022-00005
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 4, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALE AND FEMALE HALVES OF THE SKULL CLAMP ASSEMBLY, AS WELL AS THE TORQUE SCREW, WERE RETURNED TO THE MANUFACTURER. INITIAL EVALUATION AND TESTING HAS NOT IDENTIFIED ANY DISCREPANCIES OR NON-CONFORMANCES WITH THE FUNCTIONING OF THESE COMPONENTS OF THE DEVICE. NO MISSING HARDWARE, PHYSICAL ANOMALIES, OR MALFUNCTIONING HARDWARE HAS BEEN OBSERVED. A FOLLOWUP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS CONCLUDED.

    Additional Manufacturer Narrative · 0

    THE SKULL CLAMP ASSEMBLY AND TORQUE SCREW WERE RETURNED, INSPECTED, AND FUNCTIONALLY TESTED. NO DISCREPANCIES WERE OBSERVED WITH RESPECT TO FUNCTION, COMPONENT CONDITION, OR COMPONENTS PRESENT. THE MALE AND FEMALE HALVES OF THE SKULL CLAMP ASSEMBLY WERE FOUND TO BE FREE OF DAMAGE AND FREE OF EXCESS PLAY OR MOVEMENT. THE SKULL CLAMP ASSEMBLY BASE LOCKING KNOB AND ROCKER ARM (TWO-PIN) LOCKING KNOB WERE ASSESSED AND CONFIRMED TO BE FUNCTIONING AS INTENDED TO LOCK AND PREVENT MOVEMENT OF THE ROCKER ARM OR SKULL CLAMP HALVES. NO DISCREPANCIES WERE FOUND IN THE RETURNED TORQUE SCREW. THE PROBABLE CAUSE RELATES TO UINTENTIONAL USER ERROR IN THE PINNING/FIXATION TECHNIQUE PRIOR TO THE REPORTED SLIPPAGE. THE PATIENT EXPERIENCED MINOR SCRATCHES NOT REQUIRING SUTURES AND THE CASE WAS COMPLETED AFTER UNPINNING THE PATIENT'S HEAD AND RESTING ON A GEL RING.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED THAT A PATIENT'S HEAD HAD SLIPPED OUT OF THE HEAD FIXATION DEVICE'S PINS DURING AN AWAKE CRANIOTOMY PROCEDURE. THE SLIPPAGE WAS REPORTED TO OCCUR DURING DRILLING RIGHT AFTER THE PINNING PROCESS WAS COMPLETE. THE PATIENT SUFFERED SOME SCRATCHES THAT DID NOT REQUIRE SUTURES. AN MRI SCAN WAS NOT PLANNED, THUS THERE WAS NO INTERRUPTION TO IMAGING. AFTER THE SLIPPAGE, THE PATIENT WAS UNPINNED AND THE CASE WAS COMPLETED BY RESTING THE PATIENT'S HEAD ON A GEL RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592842 IMRIS HFD100 SKULL CLAMP ASSEMBLY SKULL CLAMP HBL IMRIS - DEERFIELD IMAGING, INC. HFD100 - ORT400

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female