BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYNJECT KVT GUN

    MDR report key: 25061765 · Received May 1, 2026

    Report

    Report Number
    3008583793-2026-00001
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BIOPSYBELL S.R.L.
    Product Code
    JDZ
    UDI-DI
    08033860036591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IFU FOR THE CEMENT USED STATES THAT "THE SURGEON IS RESPONSIBLE FOR ANY COMPLICATIONS OR HARMFUL CONSEQUENCES WHICH MIGHT RESULT FROM AN ERRONEOUS INDICATION OR OPERATIVE TECHNIQUE, IMPROPER USE OF THE EQUIPMENT AND FAILURE TO COMPLY WITH THE SAFETY INSTRUCTIONS GIVEN IN THE DIRECTIONS FOR USE."

    Description of Event or Problem · 0

    THE PATIENT DID HAVE CANAL COMPRESSION AND HAD TO BE MONITORED. NO OTHER PERSON IN THE ROOM WAS AFFECTED. PATIENT DID NOT HAVE MORTALITY ONLY COMPLICATION DUE TO CEMENT BEING INJECTED INTO SPINAL COLUMN. THE CEMENT WAS INJECTED AFTER WAITING FIVE MINUTES POST MIXING WITH INJECTION BETWEEN EIGHT AND 10 MINUTES, CEMENT LEAKED ON LEVEL 3 AFTER WAITING OVER 5-8 MINUTES POST MIXING. THE TROCARS WERE BEYOND THE POSTERIOR THIRD AND IN BIPEDICULAR SETUP. SURGEON BELIEVES THE KVTGUN HAD TO MUCH PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290523 EASYNJECT KVT GUN CEMENT MIXER JDZ BIOPSYBELL S.R.L. KVT GUN 25072145 08033860036591

    Patients

    Seq Age Sex Outcome Treatment
    1