BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER

    MDR report key: 1102083 · Received August 7, 2008

    Report

    Report Number
    1649384-2008-00412
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    June 23, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE DISTRIBUTOR REPORTED THAT DURING THE SURGERY THE SURGEON WAS REVISING A L4-L5 FUSION WHEN THE DRIVER BENT CAUSING A FIFTEEN MINUTE DELAY. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST. ADDITIONAL INFORMATION RECEIVED VIA EMAIL AT ABOUT ONE MONTH LATER, THE DISTRIBUTOR REPORTED THAT THE SURGEON WAS REVISING FOR EITHER REMOVAL OF HARDWARE, OR REVISING ADJACENT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER INCOMPASS HXX ABBOTT SPINE 19TL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK