BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24245671 · Received February 3, 2026

    Report

    Report Number
    24245671
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    July 23, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SURGEON PLACED THE CLAMP ON THE PATIENT. THE PINS SLIPPED CAUSING A LACERATION. THE SURGEON PLACED STAPLES IN THE SKIN. RN TOOK THAT MAYFIELD OUT OF SERVICE, AND BROUGHT A DIFFERENT ONE IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305496 DORO® SKULL CLAMP HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL BLACK FOREST MEDICAL GMBH 1001.001 N/A 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Other