BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 23242699 · Received October 8, 2025

    Report

    Report Number
    3003923584-2025-00030
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K203505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS NOT SUSPECTED THAT THERE IS A CONNECTION BETWEEN THE PIN FORCE DEVIATION DETECTED HERE AND THE DESCRIBED SLIPPAGE, AS THE DETECTED DEVIATION IS VERY MINOR (<1%). WE SUSPECT THAT MAYBE THE PINNING TECHNIQUE WAS NOT OPTIMAL, AS DESCRIBED IN 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." EVEN THOUGH NO INJURIES WERE REPORTED IN THIS CASE, WE DECIDED TO REPORT IT BASED ON CUSTOMER FEEDBACK (DESCRIPTION OF THE INCIDENT).

    Description of Event or Problem · 0

    CUSTOMER INFORMED US ON SEPTEMBER 11 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A SLIPPAGE. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512064 DORO® SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other