BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTENE

    MDR report key: 2135877 · Received April 14, 2008

    Report

    Report Number
    3004961344-2008-00001
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 11, 2008
    Manufacturer
    CEREMED, INC.
    Product Code
    MTJ
    PMA / PMN Number
    K041363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DEVELOPED ANAPHYLAXIS SHOCK DURING CARDIAC SURGERY. THE PT WAS STABILIZED AND THE SURGERY COMPLETED. ANAPHYLAXIS SHOCK IS A WELL-KNOWN BUT UNCOMMON REACTION DURING SURGERY. SEVERAL VARIABLES HAVE THE POTENTIAL FOR CAUSING THE CONDITION WHICH CAN INCLUDE ALLERGIES TO CERTAIN ANTIBIOTICS OR LATEX. OSTENE IS A WATER-SOLUBLE IMPLANT MATERIAL USED FOR THE CONTROL OF BLEEDING FROM BONE SURFACES. OSTENE IS NON-TOXIC AND CAUSES NO KNOWN ALLERGIC REACTIONS AS DEMONSTRATED BY THE BIOCOMPATIBILITY TESTING LISTED ON PAGE 1. IT DISSOLVES AND IS DISCHARGED THROUGH THE LIVER AND KIDNEYS. ACCORDING TO THE INFO PROVIDED BY THE SURGEON AND THE BIOCOMPATIBILITY TEST DATA AVAILABLE, IT IS OUR BELIEF THAT OSTENE WAS NOT THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT SUFFERED FROM ANAPHYLACTIC SHOCK DURING CARDIAC SURGERY. THE PT'S SKIN CHANGED IN STRUCTURE AND IMMEDIATE ATTENTION WAS REQUIRED TO STABILIZE HER. ACCORDING TO THE SURGEON, THIS IS A PHENOMENA THAT HE HAS SEEN BEFORE WITHOUT THE USE OF OSTENE. THE PT WAS STABILIZED AND THE SURGERY COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTENE AOC BONE WAX MTJ CEREMED, INC. BW-012 W1530806

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R