BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 11752011 · Received April 30, 2021

    Report

    Report Number
    3003923584-2021-00010
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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." WE RECOMMEND USING OUR SKULL PINS IN COMBINATION WITH OUR SKULL CLAMPS. RISKS DUE TO NOT PERMITTED SYSTEM COMBINATIONS WITH THIRD PARTY COMPONENTS COULD NOT BE EXCLUDED, AS IN THIS CASE.

    Description of Event or Problem · 1

    DISTRIBUTOR INFORMED OUR SALES DEPARTMENT ON THE 6TH OF APRIL 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
    652864 DORO QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other