BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1940641 · Received December 22, 2010

    Report

    Report Number
    1224732-2010-00029
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 12, 2009
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, STRYKER BIOTECH RECEIVED A REPORT OF AN ADVERSE EVENT IN A PT WHO RECEIVED AN OP-1 CONTAINING PRODUCT FOR AN UNK PROCEDURE ON AN UNK DATE. THE PT ((B)(6)) WAS READMITTED TO THE HOSPITAL ON (B)(6) 2009 FOR ABDOMINAL PAIN. A CT SCAN REVEALED FLUID COLLECTION WHICH THE PHYSICIAN STATED WAS LIKELY A POSTOPERATIVE HAEMATOMA. ON (B)(6)2010, STRYKER BIOTECH RECEIVED CONFIRMATION FROM THE SALES REP THAT THE PRODUCT USED IN THE PROCEDURE WAS OP-1 IMPLANT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention