BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO SKULL CLAMP RADIOLUCENT

    MDR report key: 11671108 · Received April 15, 2021

    Report

    Report Number
    3003923584-2021-00007
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 17, 2021
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435502181
    PMA / PMN Number
    K032331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE IS IN SPECIFICATION AND DID NOT SHOW ANY DEVIATION THAT COULD CAUSE THE REPORTED INCIDENT WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT 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 · 1

    DISTRIBUTOR INFORMED OUR SERVICE DEPARTMENT ON THE 17TH OF MARCH THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A SLIPPAGE THAT RESULTED IN A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573213 DORO SKULL CLAMP RADIOLUCENT DORO SKULL CLAMP RADIOLUCENT HBL PRO MED INSTRUMENTS GMBH 3034-00 04250435502181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other