BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 23705730 · Received December 3, 2025

    Report

    Report Number
    3003923584-2025-00037
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BLACK FOREST MEDICAL GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K203505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE DATE OF FINDING PREDATES THE AWARENESS DATE, AS THE INITIAL COMPLAINT DID NOT PROVIDE SUFFICIENT INFORMATION TO ESTABLISH A REPORTING OBLIGATION. THE MANUFACTURER RECEIVED A COMPLAINT ON (B)(6) REGARDING ALLEGED SLIPPAGE. AT THAT TIME, NO INJURY, MALFUNCTION, OR CLINICAL CONSEQUENCE WAS REPORTED. THE RETURNED DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS WITH NO EVIDENCE OF MALFUNCTION. THE CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION. ON (B)(6), THE MANUFACTURER WAS NOTIFIED BY THE SWEDISH COMPETENT AUTHORITY THAT THE END-USER HAD REPORTED AN INJURY ASSOCIATED WITH THE SAME EVENT. THIS INFORMATION WAS NOT AVAILABLE DURING THE INITIAL COMPLAINT ASSESSMENT AND WAS NOT PROVIDED IN RESPONSE TO THE MANUFACTURER'S REQUEST FOR FURTHER DETAILS. AS NO DEVIATIONS WERE FOUND AND THE PRODUCT SENT IN COMPLIED WITH THE SPECIFICATION, NO CAUSAL LINK COULD BE ESTABLISHED BETWEEN THE PRODUCT IN QUESTION AND THE INCIDENT DESCRIBED. OUR EXPERIENCE IS, THAT PINNING TECHNIQUE CAN CONTRIBUTE TO SLIPPAGES. IN THIS CONTEXT, WE REFER THE USER TO OUR CORRESPONDING RECOMMENDATIONS IN THE 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." FOLLOWING RECEIPT OF THE NEW INFORMATION, THE CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION ON THE INCIDENT IN QUESTION. IF FURTHER RELEVANT FINDINGS BECOME AVAILABLE, THESE WILL BE PRESENTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    SWEDISH MEDICAL PRODUCTS AGENCY 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
    2853257 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