BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 23787010 · Received December 12, 2025

    Report

    Report Number
    3003923584-0250-00038
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 12, 2025
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435500781
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THIS INVESTIGATION, NO DEFECT COULD BE FOUND IN THE PRODUCT SENT IN THAT COULD BE LINKED TO THE INCIDENT DESCRIBED. THE WORN THREADS ON THE PRODUCT'S THREADED INSERTS AND THE DAMAGED THREADED SHAFT OF THE TORQUE SCREW ARE NOT BEING CONSIDERED AS CAUSAL AND/OR CONTRIBUTING FACTORS IN RELATION TO THE SLIPPAGE REPORTED BY THE CUSTOMER. IF THE MAINTENANCE CYCLE (IN THIS CASE EXCEEDED BY 2 YEARS) PRESCRIBED IN THE PRODUCT IFU IS BEING OBSERVED, NONE OF THE WEAR AND TEAR DETECTED WOULD HAVE REMAINED UNDETECTED OR UNRESOLVED. AFTER CAREFUL EXAMINATION OF THE PRODUCT, THE INCIDENT DESCRIPTION, AND ALL RELATED DOCUMENTATION, NO CAUSAL CONNECTION CAN BE ESTABLISHED. THE CUSTOMER WILL BE ADVISED OF THE URGENCY OF ADHERING TO THE MAINTENANCE CYCLE WITHIN THE COMPLAINT CORRESPONDENCE. AS NO RELATED DEVIATIONS WERE FOUND ON THE PRODUCT IN QUESTION THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT, WE SUSPECT THAT MAYBE THE PINNING TECHNIQUE WAS NOT OPTIMAL, AS DESCRIBED IN 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." THE CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION ON THE REPORTED INCIDENT. ANY RELEVANT FINDINGS WILL BE PRESENTED IN A FOLLOW-UP REPORT, IF APPLICABLE.

    Description of Event or Problem · 0

    DISTRIBUTOR INFORMED US ON NOVEMBER 28 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT SUSTAINED SKIN LACERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696347 DORO® SKULL CLAMP DORO® QR3 SKULL CLAMP TEFLON HBL BLACK FOREST MEDICAL GMBH 3003-009 04250435500781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other