BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER

    MDR report key: 1102047 · Received August 7, 2008

    Report

    Report Number
    1649384-2008-00411
    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 Location
    UK
    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 SURGERY THE SURGEON WAS REVISING A L4-L5 FUSION WHEN THE DRIVER BENT, CAUSING A FIFTEEN MINUTE SURGICAL DELAY. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07 AUG 2008, 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 25YF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK