BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 10447972 · Received August 25, 2020

    Report

    Report Number
    3003923584-2020-00020
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 22, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED, BUT AS THERE WAS A POTENTIAL RISK (RE-PINNING OF THE PATIENTS HEAD) WE DECIDED TO REPORT THIS CASE.

    Description of Event or Problem · 1

    THE PATIENT WAS PINNED. AFTER THE PINNING THERE WAS A LOSS OF PRESSURE AT THE TIGHTENING SCREW WHILE TRYING TO ASSEMBLE THE SKULL CLAMP WITH THE SWIVEL ADAPTOR. THEREFORE THE STAFF HAD TO RE-PIN THE PATIENT WITH A DIFFERENT SKULL CLAMP. AFTER ANALYZING THE X-RAY PICTURES OF THE PATIENTS HEAD, THE HOSPITAL DECIDED, THAT THE LOSS OF THE PRESSURE WAS CAUSED BY AN ANOMALY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916570 DORO QR3 SKULL CLAMP DORO QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR