BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFD100

    MDR report key: 23723010 · Received December 4, 2025

    Report

    Report Number
    3010326005-2025-00006
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 4, 2025
    Manufacturer
    IMRIS IMAGING, INC.
    Product Code
    HBL
    UDI-DI
    00857534006592
    PMA / PMN Number
    K103493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMRIS CSE WENT ON SITE AND INSPECTED THE HFD100 DEVICE. NO ISSUES WERE FOUND OR REPORTED. THE DEVICE HAD PASSED PREVENTATIVE MAINTENANCE APPROXIMATELY THREE MONTHS PRIOR TO THIS EVENT. THE ENTIRE HEAD FIXATION DEVICE, INCLUDING THE TORQUE SCREWS, LINKAGES, AND HEAD FRAME WAS INSPECTED AND NO DISCREPANCIES OR FUNCTIONAL ISSUES WERE IDENTIFIED. BASED ON CLINICAL ASSESSMENT OF KNOWN INFORMATION, FUNCTIONAL ASSESSMENT OF SUBJECT DEVICE, AND COMMUNICATIONS WITH THE END USER, THE PROBABLE CAUSE OF THE FRACTURES IS RELATED TO POOR CONDITION OF THE PATIENT'S ANATOMY AND/OR SUBOPTIMAL DEVICE PLACEMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED A MINOR INJURY OCCURRED WHILE PINNING A SIX (6) YEAR OLD PATIENT USING THE HFD100 DEVICE DURING A CRANIOTOMY. DETAILS OF EVENT WERE PROVIDED BY A NURSE VIA EMAIL ON NOVEMBER 6, 2025. THE NURSE OBSERVED THE SKULL CLAMP WAS TIGHTENED BY THE SURGEON WHO IMMEDIATELY NOTICED A LOSS OF PRESSURE. THE SURGEON THEORIZED THE CLAMP (PART OF THE HFD100) MAY BE BROKEN OR THE PATIENT HAS A FRACTURE DUE TO A THIN SKULL. A CT OF THE PATIENT'S HEAD WAS CONDUCTED WHILE UNDER ANESTHESIA, WHICH ADDED AN ADDITIONAL 30 MINUTES TO THE OVERALL OR TIME, AND SMALL BILATERAL SKULL FACTURES WERE SEEN. IT WAS REPORTED THE SKULL FRACTURES DID NOT REQUIRE INTERVENTION. THE NEUROSURGEON USED THE HORSESHOE HEADREST IN THE SUPINE POSITION TO COMPLETE THE CRANIOTOMY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IMRIS FOLLOWED UP WITH THE CUSTOMER, WHO INDICATED THE PRESSURE APPLIED TO SKULL WAS 45 POUNDS. IT WAS FURTHER CONFIRMED THE PATIENT HAD FRACTURES ON BOTH SIDES OF THE SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140030 HFD100 HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL IMRIS IMAGING, INC. 119629-000 00857534006592

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other