BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPPORT, PATIENT POSITION

    MDR report key: 19668868 · Received July 3, 2024

    Report

    Report Number
    2921578-2024-00007
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    November 30, 2023
    Report Date
    July 1, 2024
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT REMAINS UNCLEAR WHICH MIZUHO DEVICES MAY HAVE BEEN INVOLVED IN THE INCIDENT. MIZUHO ORTHOPEDIC SYSTEMS INC. DOES NOT MANUFACTURE ACCESSORIES FOR THE C-FLEX HEAD POSITIONER, AND A REVIEW OF ITS INSTRUCTION MANUAL SUGGESTS IT IS PHYSICALLY INCOMPATIBLE WITH THE MIZUHO OSI FACE PLATE AND/OR PRONE PLATFORM, SO THE IDENTIFICATION MAY HAVE BEEN IN ERROR. THE USER FACILITY WHERE THE EVENT IS SAID TO HAVE OCCURRED HAS NOT RESPONDED TO REQUESTS FOR INFORMATION.

    Description of Event or Problem · 0

    ALLEN MEDICAL REPORTED (REF NO.MAUDE 3010216206-2023-00008) THAT ONE OF THEIR CUSTOMERS USED THE ALLEN C-FLEX HEAD POSITIONER WITH A MIZUHO FACE MASK PAD AND MIZUHO FACE PLATE. THE PATIENT WAS MALE, HAVING A POSTERIOR CERVICAL SURGERY. HE WAS IN A PRONE POSITION FOR 9 PLUS HOURS. WHEN THE PATIENT WAS TAKEN OUT OF THE POSITIONER, HE HAD DEVELOPED A SEVERE PRESSURE INJURY ON HIS CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467098 SUPPORT, PATIENT POSITION CCX MIZUHO ORTHOPEDIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other