BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, SWIVEL ADAPTER

    MDR report key: 21366381 · Received February 12, 2025

    Report

    Report Number
    2921578-2025-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 20, 2025
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430113888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INFORMATION OBTAINED DURING THE INVESTIGATION, THE END CAP OF THE SWIVEL ADAPTER CAME UNGLUED AND FELL OUT. THERE IS NO OTHER AVAILABLE FASTENING MECHANISM TO SCREW THE END CAP BACK ONTO THE DEVICE. WHILE THE INFORMATION PERTAINING TO THE LOT AND SERIAL NUMBER OF THE SWIVEL ADAPTER AND THE TABLEBASE RESPECTIVELY WAS NOT OBTAINED, THE AGE OF THE MAIN CERVICAL MANAGEMENT UNIT THAT THE SWIVEL ADAPTER IS PART OF WAS FOUND TO BE 10+ YEARS (MFG DATE- 08/26/2010). THE PRODUCT DESIGN LIFE IS 10 YEARS AS PER THE OWNER'S MANUAL AND HENCE THE ROOT CAUSE OF THE END CAP OF THE SWIVEL ADAPTER IS SUSPECTED TO BE WEAR AND TEAR/EXCESSIVE USE BEYOND THE PRODUCT LIFETIME.

    Description of Event or Problem · 0

    DURING A SUPINE ACDF PROCEDURE ON A TRIOS TABLE, THE LOCKING KNOB OF THE SWIVEL ADAPTER THAT INTERFACES WITH THE SKULL CLAMP WAS DETACHED, CAUSING THE PATIENT'S HEAD TO DROP A FEW INCHES ON THE IMAGING TOP PAD. NO INJURY REPORTED TO THE PATIENT. NEUROMONITORING INDICATED EVERYTHING WAS NORMAL.

    Description of Event or Problem · 0

    DURING A SUPINE ACDF PROCEDURE ON A TRIOS TABLE, THE LOCKING KNOB OF THE SWIVEL ADAPTER THAT INTERFACES WITH THE SKULL CLAMP WAS DETACHED, CAUSING THE PATIENT'S HEAD TO DROP A FEW INCHES ON THE IMAGING TOP PAD. NO INJURY REPORTED TO THE PATIENT. NEUROMONITORING INDICATED EVERYTHING WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904516 ASSY, SWIVEL ADAPTER MEDICAL TABLE CLAMP JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5979-323 00842430113888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other