BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24267393 · Received February 5, 2026

    Report

    Report Number
    3003923584-2026-00003
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 5, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K193438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVIATIONS IDENTIFIED ARE NOT CONSIDERED TO HAVE CAUSED OR CONTRIBUTED TO THE DESCRIBED EVENT (SLIPPAGE). DUE TO CONTAMINATION OF THE INTERNAL COMPONENTS, THE OPENLOCK MECHANISM IS MORE DIFFICULT TO LOCK THAN SPECIFIED, BUT CAN STILL BE LOCKED COMPLETELY. THE CORRECT LOCKING OF THE HANDLE WHEEL CAN AND SHOULD BE VERIFIED BY CHECKING THAT IT IS LOCKED CORRECTLY IN ACCORDANCE WITH THE IFU SPECIFICATIONS. IT IS ALSO NOT ASSUMED THAT THE SLIGHT DEVIATION IN PIN FORCE (~ 1%) AT THE HIGHEST OF THE FOUR MEASURING POINTS CONTRIBUTED TO THE SLIPPAGE. THE MAINTENANCE INTERVAL FOR THE TORQUE SCREW HAS BEEN EXCEEDED; THE DEVIATION COULD NOT HAVE REMAINED UNDETECTED DURING THE STANDARD PRODUCT INSPECTION AS PART OF THE ANNUAL MAINTENANCE SPECIFIED IN THE PRODUCT IFU. OUR EXPERIENCE IS, THAT THE PINNING TECHNIQUE IS A MAJOR FACTOR IN TERMS OF THE OCCURRENCE PROBABILITY OF SLIPPAGES. WE REFER TO OUR CORRESPONDING RECOMMENDATIONS DESCRIBED 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

    DISTRIBUTOR INFORMED US ON JANUARY 9, 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
    328292 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