BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRX SYSTEM

    MDR report key: 1996515 · Received February 18, 2011

    Report

    Report Number
    1030489-2011-00154
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    FSZ
    PMA / PMN Number
    K993021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHAT TREATMENT THE PATIENT IS RECEIVED. (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE COUPLING BETWEEN THE LIGHTSOURCE AND THE CABLE. IT IS UNKNOWN THE SEVERITY OF THE BURN. HOWEVER NO OTHER PATIENT COMPLICATIONS WERE REPORTED DURING AND AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METRX SYSTEM LIGHT, SURGICAL, CARRIER FSZ MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other