BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONESOURCE HAC

    MDR report key: 513670 · Received March 1, 2004

    Report

    Report Number
    9610726-2004-00013
    Event Type
    Injury
    Date Received
    March 1, 2004
    Date of Event
    September 16, 2003
    Report Date
    October 29, 2003
    Manufacturer
    STRYKER
    Product Code
    GXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE BONESOURCE CEMENT DEFORMED AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONESOURCE HAC BONESOURCECLASSIC HYDROXYAPATI GXP STRYKER 79-41950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention