BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1518045 · Received October 28, 2009

    Report

    Report Number
    1224732-2009-00054
    Event Type
    Other
    Date Received
    October 28, 2009
    Report Date
    October 13, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, STRYKER BIOTECH RECEIVED A REPORT OF A 'SEVERE POST OP INFECTION' IN AN UNIDENTIFIED PT WHO RECEIVED AN OP-1 PRODUCT ON AN UNK DATE. THE PHYSICIAN REPORTED THAT HE DID NOT KNOW WHETHER THE INFECTION WAS RELATED TO THE OP-1 OR NOT. ADD'L INFO WILL BE REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other