BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL TRACTION VECTOR ADJUSTER

    MDR report key: 16677760 · Received April 4, 2023

    Report

    Report Number
    2921578-2023-00003
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 30, 2023
    Report Date
    June 26, 2023
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430111679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED FOLLOWING THE EVALUATION OF THE DEVICE, IT WAS CONCLUDED THAT THE AGING OF THE BUMPER (CLAMPING COMPONENT OF THE DEVICE) SEEMED TO AFFECT THE INTEGRITY OF THE DEVICE SURFACE THUS CAUSING IN THE SLIPPING MOTION. IT WAS ALSO OBSERVED THAT THE DEVICE WAS NOT SUBJECTED TO REGULAR INSPECTION TO CHECK THE WEAR AND PERFORM CLEANING PRIOR TO THE USE DESPITE BEING MENTIONED IN THE OWNER'S MANUAL AS THE FOLLOWING WARNING- "BEFORE AND AFTER EACH USE, INSPECT THE TABLE TOP, COMPONENTS AND ACCESSORIES FOR POSSIBLE DAMAGE, EXCESSIVE WEAR OR NON-FUNCTIONING PARTS. CAREFULLY INSPECT ALL CRITICAL ACCESSIBLE AREAS, JOINTS AND ALL MOVING PARTS FOR POSSIBLE DAMAGE AND NON-FUNCTION. DAMAGED OR DEFECTIVE PARTS SHOULD NOT BE USED OR PROCESSED". THUS, PROLONG USE OF THE DEVICE WITHOUT REGULAR INSPECTION AND MAINTENANCE MAY ALSO HAVE AFFECTED THE BUMPER INTEGRITY CAUSING THE SLIPPING MOTION.

    Description of Event or Problem · 0

    PATIENT WAS HAVING A POSTERIOR CERVICAL FUSION USING GARDNER WELLS TONGS AND TRIOS VECTOR TRACTION. TRIOS VECTOR TRACTION SLIPPED MID CASE AND PATIENTS HEAD FELL AND WAS CAUGHT BY THE HORSESHOE HEADREST. PATIENT WAS NOT INJURED.

    Description of Event or Problem · 0

    PATIENT WAS HAVING A POSTERIOR CERVICAL FUSION USING GARDNER WELLS TONGS AND TRIOS VECTOR TRACTION. TRIOS VECTOR TRACTION SLIPPED MID CASE AND PATIENTS HEAD FELL AND WAS CAUGHT BY THE HORSESHOE HEADREST. PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129550 CERVICAL TRACTION VECTOR ADJUSTER OPERATING TABLE JEA MIZUHO OSI 7803-790 00842430111679

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown