BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRAYENBUEHL HK FNG REST SML

    MDR report key: 489002 · Received October 8, 2003

    Report

    Report Number
    1423507-2003-00123
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    September 9, 2003
    Report Date
    October 8, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, ANTERIOR CERVICAL DEVICE, THE PHYSICIAN WAS MOVING LIGAMENTS AND THE DEVICE SNAPPED OFF. THE BREAK OCCURRED AT THE 90 DEGREE ANGIE OF THE DEVICE. THE PATIENT REQUIRED ADDITIONAL X-RAY TO LOCATE THE FOREIGN BODY. IT IS UNKNOWN HOW MUCH ADDITIONAL INTERVENTION WILL BE REEQUIRED, AS THE PATIENT WAS STILL IN SURGERY WHEN THE CUSTOMER CALLED. FURTHER CONVERSATION WILL THE CUSTOMER REVEALED THAT THE PIECE THAT SNAPPED OFF, WAS RECOVERED IN THE DRAPE. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRAYENBUEHL HK FNG REST SML SURGICAL HOOK GDG CARDINAL HEALTH NL3086 K02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other