BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3792504 · Received May 6, 2014

    Report

    Report Number
    1030489-2014-02405
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEX ARM WOULD NOT TIGHTEN TO THE ATTACHMENT DURING AN UNSPECIFIED SPINAL SURGERY AND CAN NO LONGER BE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272070 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA MY13A001

    Patients

    Seq Age Sex Outcome Treatment
    1