BEUDAMED
    FDA Adverse Event Death Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 1945137 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00678
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE AGENCY REPORTED THAT DIFFICULTY IN BROACHING HAD CAUSED AN APPROX 30 MINUTE DELAY IN THE OPERATION, BUT THAT THIS DELAY HAD NOT CREATED A MAJOR OR LIFE THREATENING SITUATION. DURING THE FINAL SURGICAL REDUCTION AND CLOSURE, AFTER THE RSP SYSTEM WAS IMPLANTED, AN ARTERY WAS ACCIDENTLY SEVERED AND THE PT DIED FROM A SIGNIFICANT LOSS OF BLOOD. THE INSTRUMENTS AND IMPLANTS USED FOR THIS OPERATION WERE NOT READILY AVAILABLE TO DJO FOR TESTING OR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT HUMERAL BROACH, SIZE 9 HTQ ENCORE MEDICAL, L.P. 804-02-009 37694L11

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death