BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS CABLE SYSTEM

    MDR report key: 3171727 · Received June 16, 2013

    Report

    Report Number
    1030489-2013-02328
    Event Type
    Malfunction
    Date Received
    June 16, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    ISN
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CERVICAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE CABLE BROKE. THE PATIENT UNDERWENT MRI EXAMINATION AND AT THIS TIME, IT IS UNKNOWN IF THERE WILL BE A REVISION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272741 ATLAS CABLE SYSTEM CABLE ISN MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1