BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-T UNITHREAD SPIRAL SYSTEM

    MDR report key: 398729 · Received June 1, 2002

    Report

    Report Number
    79383-2002-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2002
    Date of Event
    April 11, 2002
    Report Date
    May 15, 2002
    Manufacturer
    SPINEVISION, S.A.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING SPINAL IMPLANTS FOR A L5-S1 FUSION WHEN A CONNECTOR CAME LOOSE AND PARTIALLY DISASSOCIATED. THE CONNECTOR WAS REMOVED AND REPLACED WITH ANOTHER CONNECTOR. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-T UNITHREAD SPIRAL SYSTEM SPINAL INSTRUMENTATION MAX SPINEVISION, S.A. NA 2003851D

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other