BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURO (R)

    MDR report key: 4945046 · Received July 24, 2015

    Report

    Report Number
    3003923579-2015-00004
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 3, 2015
    Report Date
    July 13, 2015
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K063494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CAN NOT FIND THE ROOT CAUSE OF THE CRACK. WE BELIEVE, THAT THE DEVICE WAS DROPPED OR CRASHED AGAINST ANYTHING. FURTHER INFORMATION ABOUT THE CIRCUMSTANCES ARE REQUESTED AT THE USER FACILITY.

    Description of Event or Problem · 1

    OUR CUSTOMER SERVICE WAS CONTACTED BY A USER FACILITY STATING THAT: "A CHIEF RESIDENT PINNED A HEAD WITH AN IMRI MAYFIELD HEAD HOLDER. SHE TESTED THE LOCK AND CHECKED STABILITY OF THE HOLDER. WHEN WE ROLLED PATIENT FROM THE STRETCHER INTO A PRONE POSITION ON THE OPERATING TABLE AND BEGAN TO LOCK THE HEAD HOLDER IN PLACE IT BECAME UNLOCKED. AFTER LOOKING AT THE HOLDER, IT WAS NOTED THAT THERE WAS A CRACK IN THE HOLDER. THIS RESULTED IN US HAVING TO ROLL THE PATIENT BACK TO THE STRETCHER AND HAVING TO BE PINNED AGAIN WITH A NEW RADIOLUCENT HEAD HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481721 DURO (R) DURO (R) RADIOLUCENT SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3034-00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention