BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO SKULL CLAMP

    MDR report key: 14257435 · Received May 2, 2022

    Report

    Report Number
    14257435
    Event Type
    Malfunction
    Date Received
    May 2, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 6, 2022
    Manufacturer
    PRO MED INSTRUMENTS INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN OPERATING ROOM FOR C1-2 TUMOR RESECTION WITH INTRADURAL/EXTRADURAL APPROACH AND MICRODISSECTION OF THE TUMOR. AFTER FINAL PRONE POSITION, SECURED IN THE SKULL CLAMP, IT WAS NOTED THAT THE SKULL PIN CLAMP HAD NOT MAINTAINED PRESSURE FROM 80LB AND WENT TO 40LB. THE PATIENT SUSTAINED A LACERATION THAT NEEDED TO BE SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145333 DORO SKULL CLAMP HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL PRO MED INSTRUMENTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA Female Other