BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON-TYPE HOOKS,7 1/2", 90 DEGREE ANGLE, SEMI-S

    MDR report key: 542046 · Received September 3, 2004

    Report

    Report Number
    2430952-2004-00024
    Event Type
    Malfunction
    Date Received
    September 3, 2004
    Report Date
    September 2, 2004
    Manufacturer
    JOSEF HEISS GMBH
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO THE DISTRIBUTOR IN JULY 2004, THE TIP OF THE RHOTON HOOK (90 DEGREE HOOK) BROKE OFF IN A PT'S NECK DURING ANTERIOR CERVICAL PROCEDURE. THE TIP WAS RECOVERED AND THERE WAS NO EFFECT TO THE PT. THE BREAKAGE DID NOT COMPROMISE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHOTON-TYPE HOOKS,7 1/2", 90 DEGREE ANGLE, SEMI-S MICROSURGICAL INSTRUMENT GZX JOSEF HEISS GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *