BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLAR

    MDR report key: 2142646 · Received May 19, 2011

    Report

    Report Number
    3008524126-2011-00013
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED, WHILE IMPLANTING THE TLIF CAGE, THE INSERTER INSTRUMENT BROKE. THE CASE WAS DELAYED BY 45 MINUTES TO REMOVE THE PIECE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLAR IMPLANT INSERTER INSTRUMENT LXH ORTHOFIX INC. 80-3267 31744-MI15

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other