BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 24332796 · Received February 13, 2026

    Report

    Report Number
    3003923584-2026-00004
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CARRIED OUT IN THIS CASE DID NOT REVEAL ANY DEVIATIONS FROM THE SPECIFICATION. HOWEVER, WITH THE CLAMP NOT LUBRICATED (NON-USE SCENARIO), A "TOOTH-ON-TOOTH" POSITION COULD BE REPRODUCED UNDER CORRESPONDINGLY EXTREME CONDITIONS, WHICH, HOWEVER, COULD NOT GO UNDETECTED BASED ON THE SAFETY CHECK SPECIFIED IN THE PRODUCT INSTRUCTIONS FOR USE AFTER SKULL FIXATION. THIS CONDITION MAY OCCUR IF THE UNLUBRICATED OR INSUFFICIENTLY LUBRICATED ARMS OF THE PRODUCT BECOME JAMMED AFTER CLAMPING THE PATIENT'S SKULL. THIS UNFAVORABLE CONDITION CAN BE DETECTED BY CHECKING THE QUICK-RELEASE BUTTON ON THE UNDERSIDE OF THE FIXED ARM OF THE SKULL CLAMP, AS IT DOES NOT LIE (COMPLETELY) FLAT AGAINST THE UNDERSIDE IN SUCH A TOOTH-TO-TOOTH POSITION. BASED ON THE DESCRIPTION OF THE INCIDENT, IT CANNOT BE EXCLUDED THAT THIS CONDITION WAS THE CAUSE OF THE SUBSEQUENT SLIPPAGE (JAMMING OF THE TILTED ARM'S TEETH). IN THE CONTEXT OF THIS COMPLAINT CORRESPONDENCE, THE CUSTOMER IS ADVISED OF THE RELEVANT IFU SPECIFICATIONS REGARDING PROPER LUBRICATION AND RELEVANT SAFETY CHECKS. FURTHERMORE, 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 JANUARY 14 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396279 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