BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUCLEOTOME

    MDR report key: 567384 · Received December 21, 2005

    Report

    Report Number
    2183911-2005-00001
    Event Type
    Other
    Date Received
    December 21, 2005
    Date of Event
    October 25, 2005
    Report Date
    December 19, 2005
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    LBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE THE TIP OF THE NUCLEOTOME PROBE DEVICE BROKE OFF IN THE INTERVETERAL DISC (LUMBAR) OF THE PATIENT. AT THE TIME OF THIS REPORT THE TIP REMAINS IN THE DISC. THE SALES REP. REPORTS THAT THE PATIENT HAS BEEN INFORMED AND THAT THE PHYSICIAN IS WORKING WITH THE PATIENT. THERE IS NO INDICATION THAT THE PATIENT HAS BEEN INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEOTOME AUTOMATED PERCUTANEOUS DISCECTOMY LBK CLARUS MEDICAL, LLC. 23500 503479

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other