BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT

    MDR report key: 769168 · Received October 6, 2006

    Report

    Report Number
    2430952-2006-00039
    Event Type
    Injury
    Date Received
    October 6, 2006
    Report Date
    October 5, 2006
    Manufacturer
    KOROS USA, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE FOLLOWING INCIDENT ON BEHALF OF THE USER FACILITY: DURING SET-UP OF THE JARITTRAK, DURING AN UNDETERMINED PROCEDURE, THE LOCKING MECHANISM FOR THE RING FAILED. THIS CAUSED A DELAY DURING THE PROCEDURE. THE USER FACILITY TRIED TO REPAIR BOTH THE HORIZONTAL FLEX, AND THE HORIZONTAL SOLID BAR AFTER DECONTAMINATION. THIS HAPPENED TWICE WITH BOTH THE STRAIGHT AND FLEX BARS. THE USER FACILITY WAS ABLE TO USE THE FLEX BAR AGAIN, AND THEN IT FAILED TO WORK. BOTH BARS HAVE BEEN REPLACED. ADDITIONAL INFO CONCERNING THE PT IMPACT AND STATUS WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT JARIT SURGICAL INSTRUMENTS LXH KOROS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention