BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICON

    MDR report key: 24505657 · Received March 4, 2026

    Report

    Report Number
    24505657
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 20, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT
    Product Code
    HTX
    UDI-DI
    04046826404338
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: WHILE PERFORMING PART OF THE PATIENT'S SPINAL SURGERY, THE TIP OF THE INSTRUMENT BEING USED (SPIKELESS KERRISON 3) BROKE OFF. NO EVIDENT HARM OCCURRED; THE BROKEN PIECE OF THE INSTRUMENT WAS EASILY RECOVERED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574037 MEDICON RONGEUR HTX MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT 57.28.33 UNKNOWN 04046826404338

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Other