BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3102513 · Received May 9, 2013

    Report

    Report Number
    1030489-2013-01612
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(6). (B)(4). LOCATION : HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A KYPHOPLASTY AT T11 AND L1 AND THROUGHOUT THE PROCEDURE, THERE WAS A CONCERN OF O2 BUT WAS ALLEVIATED BY POSITIONING AND OTHER VITALS APPEARED NORMAL WITH THE PATIENT BREATHING NORMAL. ACCORDING TO THE REPORT, ONCE THE CANNULAS AND BALLOONS WERE INSERTED AND THE CEMENT WAS BEING MIXED, THE PATIENT'S O2 LEVELS WERE NOT MAINTAINING AND THE PATIENT WAS FLIPPED SUPINE. IT WAS REPORTED THAT THE VITALS WERE NORMAL BUT THE PATIENT WAS UNRESPONSIVE FOR A PERIOD OF TIME INTRA-OPERATIVELY. THE PATIENT WAS TRANSFERRED FROM THE OFFICE TO THE HOSPITAL. IT WAS LATER DETERMINED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND PNEUMONIA, DIAGNOSED AT THE HOSPITAL. THE PATIENT RECOVERED FROM THE INFECTION AND HAD THE KYPHOPLASTY DONE AT THE HOSPITAL. PER THE REPORT, THE SECOND ATTEMPT WENT FINE AND THE PATIENT DID WELL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202945 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R