BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOVETAIL BLOCK ASSEMBLY

    MDR report key: 3994697 · Received June 11, 2014

    Report

    Report Number
    3004608878-2014-00091
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GZT
    PMA / PMN Number
    K830332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A DOVETAIL BLOCK ASSEMBLY (438A 1058) A SUBCOMPONENT OF A BUDDE HALO, WAS REPORTED TO HAVE A HOLE IN THE SLIDER RAIL OF THE UNIT. THE EVENT WAS FOUND UPON INCOMING INSPECTION; THEREFORE, THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346136 DOVETAIL BLOCK ASSEMBLY NA GZT INTEGRA LIFESCIENCES CORPORATION OH/USA 141

    Patients

    Seq Age Sex Outcome Treatment
    1