BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24647294 · Received March 20, 2026

    Report

    Report Number
    3003923584-2026-00008
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435501689
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTING CUSTOMER PROVIDED VIDEO FOOTAGE, WHICH, UPON REVIEW, SHOWED THAT THE TWO-PIN-HOLDER ADAPTER PLATE EXHIBITED ROTATIONAL MOVEMENT. THE ROCKER ARM APPEARS RIGID IN THE VIDEO AND SHOWS NO ROTATIONAL MOVEMENT, WHICH INDICATES PROPER FIXATION OF THE OPENLOCK MECHANISM. UPON RECEIPT OF THE DEVICE IN QUESTION AND THE ASSOCIATED ACCESSORIES (TWO-PIN-HOLDER ADAPTER PLATE), THE DEVICE WAS TESTED IN THE CONFIGURATION SHOWN IN THE VIDEO PROVIDED (REPORTEDLY USED WHEN THE LACERATION OCCURRED). ROTATIONAL MOVEMENT OF TWO-PIN-HOLDER ADAPTER PLATE CORRESPONDING TO THE PROVIDED VIDEO FOOTAGE WAS FOUND TO BE ONLY POSSIBLE WHEN THE RECEPTACLE (CLAMPING MECHANISM) FOR ATTACHMENT OF THE TWO-PIN-HOLDER ADAPTER PLATE IS NOT LOCKED OR INADEQUATELY LOCKED. NO DEVIATIONS WERE FOUND ON THE DEVICE. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS BEEN INFORMED OF THE INVESTIGATION RESULTS AND THE CORRESPONDING INSTRUCTIONS REGARDING PROPER INSTALLATION OF THE DEVICE AND SAFETY CHECKS PRIOR TO CLINICAL USE AS PART OF THE COMPLAINT CORRESPONDENCE. FURTHER INFORMATION HAS BEEN REQUESTED. ANY NEW FINDINGS REGARDING THIS INCIDENT MAY BE INCLUDED IN A FOLLOW-UP REPORT UPON RECEIPT.

    Description of Event or Problem · 0

    CUSTOMER INFORMED US 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
    714568 DORO® SKULL CLAMP DORO® QR3 MULTI PURPOSE SKULL CLAMP HBL BLACK FOREST MEDICAL GMBH 3020-50 04250435501689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other