BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT, ORTHOPAEDIC

    MDR report key: 5027299 · Received August 25, 2015

    Report

    Report Number
    5027299
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 21, 2015
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR DISCECTOMY, THE TIP OF THE HOEN DURAL SEPARATOR BROKE OFF INSIDE THE PATIENT WHEN STRUCK WITH A MALLET BY THE SURGEON. A C-ARM X-RAY WAS BROUGHT IN TO LOCATE THE BROKEN TIP THAT WAS IN THE PATIENT. THE BROKEN PIECE WAS RECOVERED WITHOUT HARM TO THE PATIENT. THE DEVICE WAS DISPOSED OF. MANUFACTURER RESPONSE FOR HOEN DURAL SEPARATOR, (PER SITE REPORTER): THE MANUFACTURER WAS RESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560653 INSTRUMENT, ORTHOPAEDIC LXH SYMMETRY SURGICAL INC 65-1102

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR