BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24854608 · Received April 13, 2026

    Report

    Report Number
    3003923584-2026-00012
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 10, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NO FINDINGS WERE IDENTIFIED ON THE DEVICE SUBMITTED THAT COULD BE CAUSALLY OR CONTRIBUTIVELY RELATED TO THE DESCRIBED SLIPPAGE. THE WORN THREAD INSERT AT THE TORQUE SCREW INTERFACE IS TYPICALLY CAUSED BY FREQUENT USE OF A DAMAGED COUNTERPART (TORQUE SCREW WITH A DAMAGED THREADED SHAFT) AND/OR INSUFFICIENT LUBRICATION OF THE FEATURE. AS THE DEVICE DID NOT SHOW ANY DEVIATION THAT COULD CAUSE THE REPORTED INCIDENT, WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "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

    ON (B)(6), A CUSTOMER INFORMED US THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN EVENT IN WHICH A LACERATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604972 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