BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE NEEDLE SIDE FIRING 13G, 4"

    MDR report key: 1645630 · Received March 19, 2010

    Report

    Report Number
    1526439-2010-00049
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 17, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    DYB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS (B) (6) WITH GOOD BONE. NO CONNECTION COULD BE MADE BETWEEN THE EVENT AND ANY SHORTCOMINGS OF THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTED THE BREAKAGE OF 13G SIDE OPENING NEEDLE DURING A SPINAL VBA PROCEDURE. THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PEDICLE. THE DOCTOR HAD ROTATED THE NEEDLE TO REPOSITION AND WAS NOT AWARE THAT THE TIP HAD BENT WHEN INSERTING WITHIN THE PEDICLE, AS THIS COULD NOT BE SEEN ON THE MONITOR. THE TIP WAS LEFT DOWN WITHIN THE PEDICLE. THE CASE WAS COMPLETED USING THE OTHER PEDDLE TO PLACE THE BONE CEMENT. THERE WAS NO ADVERSE PT OUTCOME, HOWEVER, AS AN UNINTENDED PORTION OF THE DEVICE WAS LEFT IN VIVO, AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR