BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRODUCER NEEDLE, 13G 4" SIDE FIRE

    MDR report key: 1675012 · Received April 26, 2010

    Report

    Report Number
    1526439-2010-00063
    Event Type
    Malfunction
    Date Received
    April 26, 2010
    Date of Event
    March 29, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT REPORTED THAT THE PATIENT HAD VERY HARD BONE AND THE NEEDLES WERE DIFFICULT TO GET INTO PLACE. CONTACT REPORTED THAT THE DOCTOR DID NOT BELIEVE IT WAS A PRODUCT DEFECT AND THAT THE ISSUE WAS RELATED TO THE PATIENT BONE QUALITY.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT SHE WAS MADE AWARE OF THE BREAKAGE OF A CONFIDENCE NEEDLE. THE HANDLE OF THE NEEDLES WERE BROKEN OR PULLED OFF THE SHAFT. THE NEEDLES BROKE OFF AT SKIN LEVEL. DR MADE AN OPEN INCISION DOWN TO THE BONE IN ORDER TO REMOVE THE NEEDLES. HE WAS ABLE TO REMOVE ALL OF THE BROKEN PIECES AND THERE WAS NO ADVERSE PATIENT INJURY AS A RESULT OF THIS SITUATION. AS THE SURGEON HAD TO GO FROM A CLOSED TO AN OPEN PROCEDURE TO ADDRESS THIS ISSUE AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE INTRODUCER NEEDLE, 13G 4" SIDE FIRE INTRODUCER NEEDLE LXH DEPUY SPINE, INC. NA CKCCPY

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR