BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADWELL

    MDR report key: 24742792 · Received March 31, 2026

    Report

    Report Number
    9710376-2026-00001
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    February 28, 2026
    Report Date
    April 20, 2026
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    PMA / PMN Number
    K130136
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RECEIVED THE FOLLOWING COMPLAINT FROM DISTRIBUTOR: "WE HAD A RETAINED NEEDLE IN A PATIENT. I'M NOT SURE THE FULL DETAILS OF THE SITUATION AND THERE WAS NOT A PICTURE OF THE ELECTRODE/NEEDLE IN QUESTION. I AM CURRENTLY INVESTIGATING BUT I WANTED YOU TO BE AWARE RIGHT AWAY THAT THERE MAY BE A PROBLEM WITH THE NEEDLE INTEGRITY." THEY WERE UNABLE TO REMOVE THE FRAGMENT WHEN IT WAS INITIALLY NOTICED DUE TO REQUIRING AN ADDITIONAL INCISION- A SECOND PROCEDURE WAS PLANNED FOR REMOVAL AT THAT TIME. THE EXACT LOT NUMBER IS NOT AVAILABLE FROM THE CUSTOMER. THEY HAD BOTH LOTS AT THE TIME OF THE INCIDENT AND ARE NOT SURE WHICH WAS USED. CUSTOMER CONFIRMED: "OUR TECHS ARE INSTRUCTED TO NEVER BEND A NEEDLE FOR PLACEMENT. THE BROKEN NEEDLE WAS PLACED AT THE MEDIAL MALLEOLUS FOR POSTERIOR TIBIAL NERVE STIMULATION. IT WAS NOT BENT FOR PLACEMENT. WAS THERE POSSIBLY SOME TORQUEING OR BENDING OF THE NEEDLE DURING REMOVAL- THE TECH DENIES IT, BUT NOT IMPOSSIBLE. THEY STATED THE NEEDLE WAS PULLED OUT STRAIGHT, IN THE REVERSE DIRECTION OF ITS PLACEMENT AND THE METAL NEEDLE BROKE UNDER THE SKIN. I ASKED IF THEY HAD TAKEN ANY PICTURES OF THE ELECTRODE OR ANYTHING BUT THEY DIDN'T. I DID SEE AN XRAY AND IT DID NOT LOOK LIKE THE FULL LENGTH OF THE NEEDLE THAT IS NORMALLY SUBDERMAL SO IT BROKE BEYOND THE POINT WHERE THE NEEDLE MEETS THE WIRE."

    Description of Event or Problem · 0

    A POSTERIOR CERVICAL SPINE FUSION PROCEDURE WAS BEING PERFORMED. THE FOLLOWING WAS REPORTED: "ELECTRODES WERE PLACED NORMALLY, POSTERIOR CERVICAL SURGERY WAS PERFORMED, TECH REMOVED ELECTRODES FOLLOWING THE PROCEDURE AND NOTICED THAT ONE ELECTRODE HAD BROKEN OFF AT THE WELD POINT INSIDE THE PATIENT (RIGHT ANKLE FOR PTN STIM). SURGEON WAS INFORMED, AND ATTEMPTS WERE MADE TO REMOVE THE NEEDLE BY THE SURGEON. DESPITE USING X-RAY, THE NEEDLE COULD NOT BE SAFELY REMOVED, AND THE SURGICAL TEAM HAD TO GO BACK TO REMOVE IT AT A LATER DATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264833 CADWELL DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, TWISTED GXZ TECHNOMED EUROPE 302869-000 102299 OR 102143

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention