BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS

    MDR report key: 18052152 · Received November 1, 2023

    Report

    Report Number
    9615788-2023-00002
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    April 6, 2023
    Report Date
    April 23, 2023
    Manufacturer
    TEKNIMED SAS
    Product Code
    NDN
    UDI-DI
    03701505800559
    PMA / PMN Number
    K221926
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) UNITS OF THE BONE CEMENT LOT 045A23071 HAVE BEEN SOLD INDIVIDUALLY BETWEEN 02-MAR-2023 AND 18-APR-2023, THIS IS THE FIRST CLAIM RECEIVED. PHYSICO-CHEMICAL CHARACTERISTICS, FUNCTIONAL CHARACTERISTICS AND MICROBIOLOGICAL CONTROLS OF THE BATCH 045A23071 ARE COMPLIANT.

    Description of Event or Problem · 0

    THE INVICTUS SPINAL CEMENT SYSTEM 17095-S LOT 060423095 IS AN ASSEMBLY OF 2 DEVICES: - PUREKIT T060425 LOT 060423014 - INVICTUS BONE CEMENT 17095-1-S LOT 045A23071 SURGEON INTENDED TO USE INVICTUS FENESTRATED SYSTEM WITH INVICTUS SPINAL CEMENT SYSTEM (17095-S) TO AUGMENT FENESTRATED SCREWS IN LUMBAR SPINE TO IMPROVE FIXATION STRENGTH IN OSTEOPOROTIC BONE. USING VISUAL INFORMATION AND A STOPWATCH, THE SPEED OF INJECTION WAS FASTER THAN WHAT IS RECOMMENDED PER THE IFU. OBSERVATIONS SHOW AN INJECTION SPEED OF APPROXIMATELY 1 REVOLUTION PER 2 SECONDS, COMPARED TO THE RECOMMENDED 1 REVOLUTION PER 4 SECONDS. VERBAL INSTRUCTIONS ON INJECTION SPEED WERE GIVEN TO THE SURGEON FROM THE SALES REPRESENTATIVE AND A DEVELOPMENT ENGINEER PRIOR TO THE START OF CEMENT INJECTION, WHICH WAS NOT FOLLOWED. APPROXIMATELY 10 MINUTES AFTER INJECTION OF CEMENT THE PATIENT EXPERIENCED AN EMBOLISM. AFTER PROMPT RESPONSE FROM THE SURGICAL TEAM, THE PATIENT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157280 INVICTUS INVICTUS BONE CEMENT NDN TEKNIMED SAS 045A23071 03701505800559

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other PUREKIT T060425