BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24399072 · Received February 20, 2026

    Report

    Report Number
    3003923584-2026-00006
    Event Type
    Injury
    Date Received
    February 20, 2026
    Report Date
    February 20, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435502181
    PMA / PMN Number
    K063494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NONE OF THE DEFECTS FOUND IN THE SKULL CLAMP RETURNED FOR EXAMINATION COULD BE LINKED TO THE DESCRIBED SLIPPAGE AS CONTRIBUTING OR CAUSAL FACTORS. THE WORN THREADS ON THE STARBURST AND THE MATERIAL ALTERATION ON THE ROCKER ARM, WHICH SLIGHTLY NARROWED THE SKULL PIN INTERFACES (DRILL HOLES), ARE ATTRIBUTABLE TO (MATERIAL-RELATED) WEAR AND TEAR OVER MANY YEARS OF USE WITHOUT MAINTENANCE. THE CRACK ON THE QUICK RAIL OF THE FIXED ARM IMPLIES EXTERNAL FORCE, WHICH, HOWEVER, DID NOT CAUSE ANY FURTHER DAMAGE/DEVIATIONS THAT COULD BE IDENTIFIED ON THE DEVICE. THE MAINTENANCE CYCLE OF ONE YEAR SPECIFIED IN THE IFU WAS NOT ADHERED TO FOR THE DEVICE IN QUESTION. THE MAINTENANCE CYCLE HAS BEEN EXCEEDED BY MORE THAN 11 YEARS. THE DEFECTS IDENTIFIED HERE WOULD NOT HAVE REMAINED UNDETECTED/UNREPAIRED DURING THE ANNUAL ROUTINE INSPECTION AND MAINTENANCE. THE REPORTING CUSTOMER IS MADE AWARE OF THIS CIRCUMSTANCE IN THE CONTEXT OF THIS COMPLAINT CORRESPONDENCE. 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

    CUSTOMER INFORMED US ON FEBRUARY 19 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH A LACERATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463320 DORO® SKULL CLAMP DORO® SKULL CLAMP RADIOLUCENT HBL BLACK FOREST MEDICAL GMBH 3034-00 04250435502181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other