BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNIFUSE (CLEARED BY FDA AS GRAFTON II EDBM)

    MDR report key: 2629436 · Received June 19, 2012

    Report

    Report Number
    2246640-2012-00013
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    January 1, 2009
    Report Date
    May 21, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K082615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO RECEIVED FROM THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. NO REVIEW OF THE APPLICABLE MFG RECORDS FOR THE IMPLANTED PRODUCT WAS POSSIBLE WITHOUT ADD'L DEVICE INFO. BASED ON THE INFO PROVIDED, WE ARE UNABLE TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, HOWEVER WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE HOSPITAL'S DERMATOLOGY DEPT REPORTED THAT THE PT HAD HAD A RESORBABLE BONE VOID FILLER ALLOGRAFT IMPLANTED DURING A LAMINECTOMY PROCEDURE IN 2009, AND HAS BEEN HAVING ISSUES WITH CONTACT DERMATITIS AND POOR WOUND HEALING OF THE ORIGINAL WOUND. THE REPORTER STATED THAT THEY HAVE NOT DETERMINED THE SOURCE OF THE PT'S COMPLICATIONS, AND THE PT IS UNDERGOING ALLERGY TESTING ON ALL GRAFTS AND DEVICES THAT THE PT PREVIOUSLY HAD IMPLANTED. NO LOT INFO OR ADD'L PT INFO WAS AVAILABLE OR PROVIDED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNIFUSE (CLEARED BY FDA AS GRAFTON II EDBM) DEMINERALIZED BONE MATRIX ALLOGRAFT MQV OSTEOTECH, INC. NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention