BEUDAMED
    FDA Adverse Event Death Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 1611792 · Received February 12, 2010

    Report

    Report Number
    1224732-2010-00006
    Event Type
    Death
    Date Received
    February 12, 2010
    Report Date
    January 22, 2010
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 22-JAN-2010, STRYKER BIOTECH RECEIVED A REPORT THAT A PT WHO RECEIVED OP-1 PUTTY ON AN UNK DATE AS PART OF AN UNK PROCEDURE DEVELOPED A DURAL TEAR IN THE SPINAL CORD AND SUBSEQUENTLY DIED. THE SURGEON REPORTED THAT HE WAS 'NOT CONFIDENT' THAT THE EVENTS WERE IN ANY WAY RELATED TO THE USE OF THE OP-1 IMPLANT. NO ADDITIONAL DETAILS WERE PROVIDED. FOLLOW UP INFO RECEIVED ON 29-JAN-2010 CONFIRMED THAT THE PT, A MALE WHO HAD UNDERGONE MULTIPLE PREVIOUS LUMBAR SURGERIES, RECEIVED OP-1 PUTTY IN CONJUNCTION WITH STRYKER XIA HARDWARE AS PART OF A PROCEDURE TO TREAT PSEUDARTHROSIS. THE PHYSICIAN STATED THAT THE OP-1 WAS PREPARED 'AS PER ROUTINE' AND WAS USED IN CONJUNCTION WITH GEL FOAM (NOS) AND TITANIUM HARDWARE (NOS). APPROXIMATELY 1-2 HOURS POSTOPERATIVELY, THE PT EXPERIENCED UNCONTROLLED SEIZURES AND DIED APPROXIMATELY TWO WEEKS LATER. AN MRI OF THE LUMBOSACRAL SPINE WAS TAKEN BUT RESULTS WERE NOT PROVIDED. THE PHYSICIAN ALSO REPORTED THAT THE PT WAS SENT TO THE ICU OF A TERTIARY CARE HOSPITAL FOR MANAGEMENT OF THE ADVERSE EVENTS. THE EVENTS WERE REPORTED TO HAVE LASTED APPROXIMATELY 1-2 WEEKS. THE PHYSICIAN STATED THAT HE FELT IT WAS POSSIBLE THAT THE EVENTS WERE RELATED TO THE USE OF THE OP-1 PUTTY. ADDITIONAL INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 PUTTY (OSTEOGENIC PROTEIN 1) IMPLANT MPY STRYKER BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death