BEUDAMED
    FDA Adverse Event Other Summary report: N

    HFD 100SKULL CLAMP ASSEMBLY

    MDR report key: 2629950 · Received June 11, 2012

    Report

    Report Number
    3003807210-2012-00003
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    IMRIS INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN IMRIS CUSTOMER SUPPORT SERVICE TECHNICIAN ON-SITE WAS INFORMED BY THE CUSTOMER THAT ONE OF THE HFD100 SKULL CLAMP ADAPTOR ASSEMBLY HAD A CRACK ABOVE THE SCREW TO THE POINT WHERE IT ATTACHES TO THE HFD100 SKULL CLAMP. THE CRACK WAS NOTICED BY THE CUSTOMER DURING PATIENT POSITIONING, AS THEY WERE TIGHTENING THE COMPONENT. THERE WAS NO REPORT OF PATIENT INJURY. IMRIS' DEVICE SAFETY BOARD CONCLUDED THAT INVESTIGATION AND ROOT CAUSE ANALYSIS WAS REQUIRED. UPON RETURN OF THE DEVICE TO IMRIS, A ROOT CAUSE INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFD 100SKULL CLAMP ASSEMBLY NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) HBL IMRIS INC. 111215-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK