BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL COMPACT H.R. ASSEMBLY

    MDR report key: 2459208 · Received February 10, 2012

    Report

    Report Number
    1222895-2012-00004
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 10, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC
    Product Code
    HAW
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS PREPARING THE PATIENT FOR THE COMPUTERIZED AXIAL TOMOGRAPHY, THE SURGEON STARTED TO ADJUST THE UCHRA AND ONE OF THE 4 HEAD POST ATTACHMENT TITANIUM SCREWS BROKE. THE CASE WAS DELAYED FOR ABOUT 30 MINUTES AS THE SURGEON WORKED WITH THE BIOMED DEPARTMENT TO FIND A SUITABLE SCREW AS A REPLACEMENT. THE CASE CONTINUED WITH A STANDARD STEEL SCREW FROM THE BIOMED DEPARTMENT. THERE WAS NO REPORTED INJURY FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL COMPACT H.R. ASSEMBLY NA HAW INTEGRA BURLINGTON, MA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1