BEUDAMED
    FDA Adverse Event Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 936377 · Received October 30, 2007

    Report

    Report Number
    1224732-2005-00043
    Date Received
    October 30, 2007
    Report Date
    October 23, 2007
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT (GAR-15), WHO RECEIVED OP-1 PUTTY FOR AN UNKNOWN INDICATION, EXPERIENCED MUSCLE SPASMS AND FATIGUE. THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE SURGEON DID NOT SUSPECT THE EVENTS WERE RELATED TO THE USE OF THE OP-1 PUTTY. THE EVENTS WERE DEEMED NONSERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 PUTTY (OSTEOGENIC PROTEIN 1) IMPLANT MPY STRYKER BIOTECH 30050 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR