BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24158741 · Received January 23, 2026

    Report

    Report Number
    3003923584-2026-00002
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    January 23, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO APPARENT CONNECTION BETWEEN THE DEVIATION DETECTED IN THIS INVESTIGATION (LOOSE THREADED INSERT ON THE FIXED ARM) AND THE REPORTED SLIPPAGE. ANY DEVIATIONS DUE TO NON-COMPLIANCE WITH THE MAINTENANCE CYCLE SPECIFIED IN THE IFU MAY REMAIN UNDETECTED IF INSPECTION AND MAINTENANCE ARE NOT CARRIED OUT, THEREFORE THE REPORTING CUSTOMER IS ADVISED OF THE IMPORTANCE OF COMPLYING WITH THE MAINTENANCE INTERVAL WITHIN THIS COMPLAINT CORRESPONDENCE. FROM OUR EXPERIENCE, PINNING TECHNIQUE PLAYS A SIGNIFICANT ROLE IN SLIPPAGE DURING SKULL FIXATION, SO IT CANNOT BE EXCLUDED THAT THE PINNING OF THE PATIENT'S SKULL MAY NOT HAVE BEEN OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "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 (B)(6) 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
    224356 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