BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRX SYSTEM

    MDR report key: 1952966 · Received January 7, 2011

    Report

    Report Number
    1030489-2011-00021
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    May 22, 2008
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    FSZ
    PMA / PMN Number
    K993021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MINI-INVASIVE DISCECTOMY PROCEDURE AT L5-S1 TWO YEARS AGO AND A ILLUMINATE SYSTEM WAS USED AT THE SURGERY. DURING THE SURGERY, THE LIGHT SOURCE WHERE IT PLUGS IN WAS DRAPED ACROSS THE PATIENT. AFTER THE SURGERY, IT WAS NOTICED THAT THE PATIENT'S BACK BURNED BY THE CONNECTOR BETWEEN LIGHT SOURCE AND THE CABLE. THE BURN AREA WAS TREATED IN THE OR BEFORE THE PATIENT LEFT THE ROOM. THERE WAS A CIRCLE MARK LEFT WHERE THE PLUG WAS DRAPED OVER THE PATIENT. THE PATIENT REPORTEDLY RECEIVED THE POST-OP TREATMENT FOR THE BURN. REPORTEDLY, THE PATIENT HAD THE DERMATOLOGY ISSUES AFTER THE TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention