BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 1380092 · Received May 8, 2009

    Report

    Report Number
    1224732-2009-00024
    Event Type
    Injury
    Date Received
    May 8, 2009
    Report Date
    April 21, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2009, STRYKER BIOTECH RECEIVED A REPORT THAT A FEMALE PT, WHO RECEIVED OP-1 PUTTY O IN 2007, AS PART OF A REVISION LUMBAR DECOMPRESSION AND FUSION WITH INSTRUMENTATION DEVELOPED A POSTOPERATIVE WOUND INFECTION. THE PT WHO HAD BEEN DIAGNOSED WITH SYSTEMIC LUPUS ERYTHEMATOSUS, WAS ALSO REPORTED TO BE IMMUNOCOMPROMISED AND OSTEOPOROTIC. CONCOMITANT MEDICATIONS INCLUDED STEROIDS (NOS). THE PHYSICIAN REPORTED THAT THE INFECTION WAS SERIOUS, REQUIRING HOSPITALIZATION, AND THAT AN UNSPECIFIED SURGICAL EXPLORATION WAS PERFORMED. THE PT WAS REPORTED TO HAVE RECOVERED FROM THE EVENT. THE PHYSICIAN STATE THAT HE DID NOT BELIEVE THE EVENT WERE RELATED TO THE USE OF THE OP-1 PUTTY. ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R