BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80 LB. TORQUE SCREW ASSEMBLY

    MDR report key: 2180873 · Received May 5, 2011

    Report

    Report Number
    3004608878-2011-00059
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 5, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) FEMALE PT WITH AN UNDERLYING MEDICAL CONDITION OF KYPHOSIS UNDERWENT A CERVICAL POSTERIOR SPINAL FUSION, 4 LEVELS. THE 80 POUND TORQUE SCREW (41B1419) WAS USED WITH THE MAYFIELD TRIAD SKULL CLAMP. IT WAS REPORTED THAT AFTER THE SURGICAL CASE, THE "TORQUE KNOB WAS STUCK ON THE PT'S HEAD." IT WOULD NOT RELEASE THE PRESSURE. A WRENCH HAD TO BE USED TO REMOVE IT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 80 LB. TORQUE SCREW ASSEMBLY NA HBL INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR