BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICOTEC TORQUE WRENCH

    MDR report key: 18266154 · Received December 5, 2023

    Report

    Report Number
    3006493760-2023-00005
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 5, 2023
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640140431994
    PMA / PMN Number
    K222789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER IMPLANTED ICOTEC IMPLANT DEVICES (PEDICLE SCREWS AND NUT SCREWS) TOGETHER WITH PEDICLE RODS FROM ANOTHER MANUFACTURER. THIS IS A CASE OF ABNORMAL (OFF-LABEL) USE. DURING THE INVESTIGATION OF THE DEVICES INVOLVED, IT WAS DETECTED THAT THE TORQUE WRENCH LIMITING FUNCTION OF THE WRENCH USED TO TIGHTEN THE NUT SCREWS DURING IMPLANTATION WAS NOT FUNCTIONING CORRECTLY. DUE TO THE MALFUNCTION, THE NUT SCREWS MAY NOT HAVE BEEN TIGHTENED SUFFICIENTLY AND THEREFORE BECAME LOOSE. THE INSPECTION OF THE DEVICE AT THE SUPPLIER SHOWED AN UNTIGHT WELDING SEAM, WHICH ALLOWED LIQUIDS (E.G. CLEANING OR DISINFECTION AGENTS) AND/OR STEAM TO ENTER THE INSIDE OF THE TORQUE WRENCH DURING PROCESSING. THUS LEADING TO CORROSION OF THE MECHANICAL COMPONENTS LEADING TO MALFUNCTION OF THE TORQUE LIMITING FUNCTION. TO INFORM USERS OF DEVICES THAT MAY ALSO BE AFFECTED AND TO PREVENT THEIR FURTHER USE, A RECALL IS BEING CARRIED OUT.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A SURGERY. DURING A POST-OP CHECK 7-10 DAYS AFTER, IT WAS DETECTED THAT SIX OUT OF EIGHT NUT SCREWS HAD LOOSENED. A REVISION SURGERY HAD TO BE CARRIED OUT. THE LOOSENED NUT SCREWS AND THE PEDICLE SCREWS WERE REMOVED AND REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232774 ICOTEC TORQUE WRENCH PEDICLE SCREW SYSTEM NKB ICOTEC AG 42-702 N.A. 07640140431994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention