BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 1081620 · Received July 28, 2008

    Report

    Report Number
    1224732-2008-00025
    Event Type
    Other
    Date Received
    July 28, 2008
    Report Date
    July 25, 2008
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 06/25/08, STRYKER BIOTECH REC'D TWO REPORTS OF HETEROTOPIC OSSIFICATION OF THE ILIOPSOAS MUSCLE IN TWO PATIENTS WHO REC'D OP-1 PUTTY FOR AN UNSPECIFIED PROCEDURE. PLEASE REFER TO MDR 1224732-2008-00024 FOR INFO REGARDING THE FIRST CASE. THE PHYSICIAN REPORTED THE EVENT TO (B) (6) IN (B) (6) 2008 BUT STRYKER BIOTECH DID NOT LEARN OF THE CASE UNTIL 06/25/08. THREE ATTEMPTS TO FOLLOW UP WITH THE PHYSICIAN WERE MADE BUT NO ADDITIONAL INFO WAS REC'D. NO ADDITIONAL INFO IS EXPECTED.

    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 Other