BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS UNIT

    MDR report key: 7864476 · Received September 11, 2018

    Report

    Report Number
    3004105610-2018-00082
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 16, 2018
    Report Date
    September 11, 2018
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS EVENT IS RELATED TO A JTS DRIVE UNIT WHICH IS USED IN CONJUNCTION WITH THE JTS NON-INVASIVE EXTENDIBLE IMPLANT (K092138). AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JTS DRIVE MOTOR UNIT HAD ERROR '8' DISPLAYED AND IT WAS CONSIDERED A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705534 JTS UNIT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE 907-120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other