BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 23776286 · Received December 11, 2025

    Report

    Report Number
    3003923579-2025-00036
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 8, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS NOT ASSUMED THAT THE SLIGHT DEVIATION IN CLAMPING FORCE DETECTED HERE CONTRIBUTED TO THE SLIPPAGE REPORTED. DUE TO THE DEVIATIONS FOUND IN THE EXTENSION ARM OF THE PRODUCT DURING THIS INVESTIGATION, IT CANNOT BE EXCLUDED THAT A TOOTH-ON-TOOTH POSITION OF THE EXTENSION ARM AND FIXED ARM OCCURED AND THAT SUBSEQUENT MOVEMENT OF THE TILTED TEETH DID CONTRIBUTE TO THE DESCRIBED SLIPPAGE. STIFFNESS AND PREMATURE WEAR OF THE EXTENSION ARM TEETH ARE TYPICAL CONSEQUENCES OF INSUFFICIENT LUBRICATION OF THE RELEVANT FEATURES AS WELL AS POSSIBLE EXTERNAL FORCE. IN THIS CONTEXT, WE REFER IN PARTICULAR TO THE INSTRUCTIONS IN THE PRODUCT'S IFU REGARDING PROPER HANDLING AND CARE (LUBRICATION & REPROCESSING) OF THE SKULL CLAMP. SINCE THE MAINTENANCE INTERVAL FOR THE PRODUCT IN QUESTION WAS NOT MET IN THIS CASE, IT IS ASSUMED THAT ANY DEVIATIONS DETECTED COULD HAVE BEEN IDENTIFIED AND RECTIFIED DURING THE ANNUAL PREVENTIVE MAINTENANCE. FROM OUR EXPERIENCE, THE PINNING TECHNIQUE CAN CONTRIBUTE TO A LOSS OF CLAMPING FORCE AND/OR SLIPPAGES. IN THIS CONTEXT, WE REFER TO 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 NOVEMBER 11 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2732454 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