BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARALLAX ACRYLIC RESIN WITH TRACERS

    MDR report key: 2854069 · Received November 29, 2012

    Report

    Report Number
    1226344-2012-00010
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 28, 2012
    Manufacturer
    NEUROTHERM
    Product Code
    NDN
    PMA / PMN Number
    K042947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED KYPHOPLASTY PROCEDURE ON (B)(6) 2012 AT (B)(6) CENTER. DURING THE PROCEDURE, THE PHYSICIAN NOTED EXCESSIVE BLEEDING FROM THE INCISION SITE, HOWEVER BLEEDING WAS CONTROLLED. EMPLOYEE OF THE (B)(6) CENTER NOTIFIED NEUROTHERM EMPLOYEE ON (B)(6) 2012 THAT THE PT HAD BEEN ADMITTED TO THE HOSPITAL. ON (B)(6) 2012, NEUROTHERM WAS ADVISED THAT PT DEATH OCCURRED ON (B)(6) 2012. AN INVESTIGATIVE CALL WAS HELD BETWEEN NEUROTHERM REGULATORY AFFAIRS AND THE PHYSICIAN ON (B)(4) 2012, WHERE PHYSICIAN INDICATED THAT THE DEVICE DID NOT MALFUNCTION. PHYSICIAN STATED THAT THE PT HAD POST PROCEDURAL COMPLICATIONS AND AN EXISTING "DO NOT RESUSCITATE ORDER" (DNR) ESTABLISHED PRIOR TO RECEIVING THE KYPHOPLASTY PROCEDURE. "WHILE IN THE HOSPITAL RECEIVED FRESH FROZEN PLASMA AND A BLOOD TRANSFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARALLAX ACRYLIC RESIN WITH TRACERS BONE CEMENT NDN NEUROTHERM KP-PAR-003 PX089

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death