BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 25239993 · Received May 21, 2026

    Report

    Report Number
    3003923584-2026-00013
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SKULL CLAMPS WERE RETURNED; ACCORDING TO THE INFORMATION PROVIDED BY THE REPORTING CUSTOMER, BOTH WERE USED DURING A PROCEDURE THAT RESULTED IN A LACERATION TO THE PATIENT. UPON FURTHER INQUIRY, THE REPORTING CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING WHICH OF THE TWO SKULL CLAMPS WAS IN USE WHEN THE PATIENT SUSTAINED THE LACERATION. INFORMATION REGARDING THE REASON FOR REPLACING THE FIRST SKULL CLAMP IS ALSO UNAVAILABLE. FURTHERMORE, A DECREASE IN CLAMPING FORCE WAS REPORTEDLY OBSERVED. HOWEVER, BASED ON CURRENT INFORMATION, IT IS UNCLEAR AT WHAT POINT IN TIME AND ON WHICH CLAMP THIS WAS OBSERVED. THE DEVIATIONS IDENTIFIED DURING THE INSPECTION OF THE FIRST SKULL CLAMP (WORN STARBURST TEETH, PIN BORE TOO TIGHT) COULD PRESUMABLY NOT HAVE CAUSED OR CONTRIBUTED TO THE SLIPPAGE. ADDITIONALLY, THE MAINTENANCE INTERVAL FOR THE DEVICE IN QUESTION WAS EXCEEDED BY 16 YEARS. ANY DEVIATIONS DETECTED WITHIN THIS INVESTIGATION COULD HAVE BEEN IDENTIFIED AND RECTIFIED DURING THE ANNUAL PREVENTIVE MAINTENANCE. THE MANUFACTURE DATE OF THIS DEVICE (3003-00, 903139) IS JANUARY 3, 2000; THIS REFERS TO FIELD H4. THE SECOND SKULL CLAMP SENT IN WAS COMBINED WITH A TORQUE SCREW FROM A THIRD-PARTY MANUFACTURER. IT IS NOT POSSIBLE TO VERIFY THE CONFORMITY OF THE THIRD-PARTY PRODUCT (CLAMPING FORCE VERIFICATION). APART FROM THIS THIRD-PARTY COMPONENT, THE SKULL CLAMP DID NOT SHOW ANY DEVIATIONS. RISKS DUE TO IMPERMISSIBLE COMBINATIONS (THIRD PARTY TORQUE SCREW) CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO ADVERSE EVENTS SUCH AS A LOSS OF CLAMPING FORCE. THE MANUFACTURE DATE OF THIS DEVICE (1001.001, 1602077) IS FEBRUARY 26, 2016; THIS REFERS TO FIELD H4. FURTHERMORE, FROM OUR EXPERIENCE, THE PINNING TECHNIQUE CAN CONTRIBUTE TO A LOSS OF CLAMPING FORCE AND/OR SLIPPAGES. IN THIS CONTEXT, WE REFER TO 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 MAY 1 THAT TWO OF OUR PRODUCTS WERE INVOLVED IN A CASE IN WHICH THE TREATED PATIENT WAS INJURED WITH A LACERATION IN THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134033 DORO® SKULL CLAMP DORO® QR2 SKULL CLAMP/ DORO® QR3 SKULL CLAMP HBL BLACK FOREST MEDICAL GMBH 3003-00/ 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1