BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIRSCHNER

    MDR report key: 62304 · Received January 9, 1997

    Report

    Report Number
    62304
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    November 26, 1996
    Report Date
    December 4, 1996
    Manufacturer
    KIRSCHNER MEDICAL CORP.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STERILE BOX LABELED "MODULAR SCREW FIXED GLENOID, COMPONENT, METAL BACK, PLASMA SPRAYED, STANDARD". THE BOX WAS NOT THE METAL BACK GLENOID COMPONENT. THE CASE WAS DELAYED FOR TWENTY-FIVE MINUTES WHILE WAITING THE ARRIVAL OF CORRECT PROSTHESIS FROM ANOTHER HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIRSCHNER Implant MODULAR GLENOID COMPONENT HSD KIRSCHNER MEDICAL CORP. * 009924

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR