BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 3113133 · Received May 9, 2013

    Report

    Report Number
    8031000-2013-00028
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY "THE SCREW DRILLING STOPPED" AND THE DEVICE WOULD NO LONGER FUNCTION. IT WAS REPORTED THAT THE BATTERY AND ATTACHMENT WERE CHANGED; HOWEVER THE DEVICE REMAINED NON-FUNCTIONAL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL DETAILS ARE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202702 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T UNIVERSAL MODULAR ELECTRIC/BATTERY DOU HAB ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1