BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 13441606 · Received February 3, 2022

    Report

    Report Number
    3010326005-2019-00025
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    April 23, 2019
    Report Date
    September 16, 2019
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HFD100 SKULL CLAMP WAS INSPECTED AS PART OF ROUTINE PREVENTIVE MAINTENANCE AND THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS. THE TORQUE SCREW (PART NUMBER 111236-000, SERIAL # (B)(4)) THAT WAS USED WITH THE HFD100 WAS RETURNED TO IMRIS-DEERFIELD IMAGING AND EVALUATED. THE TORQUE SCREW WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS. THE PATIENT WAS A REFERRED PEDIATRIC PATIENT AND THE CONDITION OF THEIR SKULL MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY HOWEVER, DATA WAS NOT AVAILABLE FROM THE HOSPITAL TO FURTHER ASSESS THE PATIENT'S CONDITION. THIS MDR IS BEING SUBMITTED OUTSIDE OF THE REQUIRED TIMEFRAME AS PART OF REMEDIAL ACTION INITIATED BY THE MANUFACTURER, IN RESPONSE TO INTERNALLY IDENTIFIED ISSUES REGARDING FAILED ELECTRONIC SUBMISSIONS THROUGH WEBTRADER.

    Description of Event or Problem · 0

    ON (B)(6) 2019, A PEDIATRIC PATIENT HAD UNDERGONE A NEUROSURGICAL PROCEDURE AND INTRA-OPERATIVE SCANNING WAS PERFORMED. AFTER THE DRAPES WERE REMOVED, THE OPERATING ROOM STAFF NOTICED THAT THE SKULL PIN IN THE IMRIS HFD100 SKULL CLAMP HAD PENETRATED THE PATIENT'S SKULL. THE HEMORRHAGE WAS REPAIRED AND SUTURED. A FOLLOW UP WAS MADE HOWEVER, NO ADDITIONAL INFORMATION PERTAINING TO THE PATIENT'S CURRENT CONDITION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289553 IMRIS HFD100 SKULL CLAMP ASSEMBLY HEAD FIXATION DEVICE / SKULL CLAMP HBL IMRIS - DEERFIELD IMAGING, INC HFD100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other