BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 14402887 · Received May 14, 2022

    Report

    Report Number
    3010326005-2022-00006
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    April 10, 2022
    Report Date
    April 13, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    HBL
    UDI-DI
    00857534006608
    PMA / PMN Number
    K103493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS AND FURTHER DETAILS ARE BEING SOUGHT FROM THE USER REGARDING THIS REPORT. IMRIS IS ATTEMPTING TO ARRANGE RETURN OF THE HFD100 DEVICE SUBJECT OF THIS REPORT FOR FURTHER ANALYSIS; TRAVEL TO THE CUSTOMER SITE IS CURRENTLY RESTRICTED DUE TO COVID.

    Additional Manufacturer Narrative · 0

    THE MALE AND FEMALE SKULL CLAMP HALVES, WHICH ARE COMPONENTS OF THE HFD100 HEAD FIXATION DEVICE, WERE RETURNED TO THE MANUFACTURER AND INVESTIGATED. NO DEVICE DEFICIENCIES RELATED TO EXCESS MOVEMENT PLAY BETWEEN THE SKULL CLAMP HALVES WERE FOUND DURING INVESTIGATION. THE UNIT WAS FREE FROM DAMAGE OR DEFECTS AND EXHIBITED NO MISSING HARDWARE OR RATCHETING TEETH WHERE THEY CONNECT. THE BASE LOCKING KNOB WHICH LOCKS THE TWO CLAMP HALVES TOGETHER WAS FUNCTIONALLY TESTED AND MET REQUIREMENTS. ONCE PINNING LOAD IS APPLIED THE TWO HALVES LOCK TOGETHER TO FORM A RIGID CONNECTION AND THE USER COMPLAINT LIKELY STEMMED FROM ASSEMBLY STEPS WITHOUT LOAD APPLIED. OVERALL THE RETURNED DEVICE MET SPECIFICATION AND NO PATIENT OR PROCEDURAL IMPACT WAS REPORTED BY THE END USER. DURING EVALUATION, THE HEAD OF ONE OF SIX SCREWS ON THE ROCKER ARM LOCKING KNOB WAS OBSERVED TO BE MISSING. THIS INCIDENTAL FINDING DID NOT IMPACT ROCKER ARM FUNCTION AND IS UNRELATED TO THE COMPLAINT ISSUE OF MOVEMENT BETWEEN THE SKULL CLAMP HALVES. DEVICE SERIAL NUMBER WAS CONFIRMED AND INCLUDED IN THIS FOLLOWUP REPORT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE FEMALE AND MALE SKULL CLAMP COMPONENTS OF THEIR HFD100 DEVICE APPEAR TO EXHIBIT SLIGHT MOVEMENT IN RELATION TO EACH OTHER AFTER BEING FIXED WITH THE LOCKING MECHANISM. THE CUSTOMER ALSO REPORTED THIS MOVEMENT COULD IMPACT THEIR LITT CASES. NO ADVERSE PATIENT CONSEQUENCES OR PROCEDURAL OUTCOMES HAVE BEEN REPORTED IN CONNECTION WITH THIS INFORMATION. FURTHER INFORMATION AND ACCESS TO THE SPECIFIC HFD100 DEVICE AND COMPONENTS IS BEING SOUGHT FROM THE CUSTOMER TO INVESTIGATE THE CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395681 IMRIS HFD100 SKULL CLAMP ASSEMBLY SKULL CLAMP HBL IMRIS - DEERFIELD IMAGING, INC. HFD100 - ORT100/200/300 00857534006608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown