BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24647273 · Received March 20, 2026

    Report

    Report Number
    3003923584-2026-00011
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K203505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE PRODUCT IN QUESTION COMPLIES WITH THE SPECIFICATION AND NO DEVIATIONS WERE FOUND THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT, WE SUSPECT THAT MAYBE THE PINNING TECHNIQUE WAS NOT OPTIMAL, AS DESCRIBED IN THE PRODUCT'S INSTRUCTION MANUAL (SECURE THE PATIENT'S HEAD TO THE SKULL CLAMP): "ADJUST THE SKULL CLAMP TO THE WIDTH OF THE PATIENT'S HEAD IN THE MANNER THAT THE TWO SKULL PINS IN THE ROCKER ARM ARE EQUIDISTANT FROM THE CENTERLINE OF THE HEAD AND THE SINGLE SKULL PIN AT THE EXTENSION ASSEMBLY IS IN LINE WITH THIS CENTERLINE."

    Description of Event or Problem · 0

    CUSTOMER INFORMED US ON MARCH 17 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713033 DORO® SKULL CLAMP DORO® QR3 SKULL CLAMP HBL BLACK FOREST MEDICAL GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other