BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLPORT MASTOID SEARCHER 6 1/2"

    MDR report key: 165176 · Received April 29, 1998

    Report

    Report Number
    1423507-1998-00135
    Event Type
    Malfunction
    Date Received
    April 29, 1998
    Date of Event
    February 13, 1998
    Report Date
    April 29, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    JZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TIP ON THE MASTOID SEARCHER BROKE OFF DURING A CERVICAL SPINE PROCEDURE. THE BROKEN TIP WAS NOT SEEN BY THE NAKED EYE NOR ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLPORT MASTOID SEARCHER 6 1/2" INSTRUMENT JZC ALLEGIANCE HEALTHCARE AU5680 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other