BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24628950 · Received March 18, 2026

    Report

    Report Number
    3003923584-2026-00010
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 18, 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
    AK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE FINDINGS OF THE INVESTIGATION, NO DIRECT CAUSAL LINK CAN BE ESTABLISHED BETWEEN THE SKULL CLAMP THAT WAS SENT AND THE INCIDENT DESCRIBED. DAMAGE WAS OBSERVED ON THE TEETH ON THE UNDERSIDE OF THE EXTENSION ARM, AS WELL AS IMPACT MARKS ON THE SURFACE OF THE COMPONENT, INDICATING IMPROPER/ ROUGH HANDLING. IN GENERAL, IF THE PRODUCT IS HANDLED IMPROPERLY (E.G., DUE TO EXTERNAL FORCES) AND/OR MAINTAINED IMPROPERLY (PARTICULARLY WITH REGARD TO LUBRICATION OF THE RELEVANT COMPONENTS), IT CANNOT BE EXCLUDED THAT THE TEETH MAY BECOME MISALIGNED (SKULL CLAMP ARMS JAMMED) AND THAT SUBSEQUENT ENGAGEMENT OF THE TEETH MAY CAUSE SLIPPAGE. HOWEVER, THIS CAN BE PREVENTED BY PERFORMING THE SAFETY CHECKS SPECIFIED IN THE IFU AND BY ADEQUATELY LUBRICATING THE COMPONENTS RELEVANT TO THE RUNNING CHARACTERISTICS. A CORRESPONDING MISALIGNMENT COULD NOT BE REPRODUCED ON THE DEVICE IN QUESTION DURING THIS INVESTIGATION. 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 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED AN INJURY FROM PINS SLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689888 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