BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER

    MDR report key: 1060073 · Received June 11, 2008

    Report

    Report Number
    1649384-2008-00302
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROD IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUEST HAS BEEN MADE TO OBTAIN THE PROD. EVAL IS PENDING UPON THE RETURN OF THE PROD.

    Description of Event or Problem · 1

    IN 2008, THE DISTRIBUTOR REPORTED THAT DURING A REMOVAL SURGERY AFTER FUSION, THE DRIVER BROKE AT THE PRONGS WHEN THE SURGEON WAS ATTEMPTING TO EXPLANT THE CLOSURE TOPS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE MALFUNCTION HAS RESULTED IN INTERVENTION IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER INCOMPASS HXX ABBOTT SPINE, INC. 21DC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK