BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRODUCER NEEDLE, DIAMOND TIP, 13G 4"

    MDR report key: 1604015 · Received February 16, 2010

    Report

    Report Number
    1526439-2010-00028
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 21, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETAINED BY THE FACILITY AND NOT MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND VERIFIED THAT THE PRODUCT MET SPECIFICATION WHEN RELEASED TO STOCK. AT THIS TIME NO CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 1

    SURGEON WAS USING BONE CEMENT IN THE SPINE. AFTER PLACING THE CEMENT IN THE VERTEBRAL BODY, HE REMOVED THE NEEDLE FROM L3 WITHOUT ISSUE. WHEN ATTEMPTING TO REMOVE THE NEEDLE AT L2 THE HANDLE PULLED FREE FROM THE NEEDLE SHAFTS. EACH TIME DOCTOR TRIED TO PULL THE NEEDLE FREE, THEN A PORTION BROKE OFF. HE BROKE THE NEEDLE OFF AT THE PEDICLE INTERFACE LEAVING A PORTION OF THE NEEDLE WITHIN THE VERTEBRAL BODY. THERE WAS NO ADVERSE PT OUTCOME REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE INTRODUCER NEEDLE, DIAMOND TIP, 13G 4" INTRODUCER NEEDLE DYB DEPUY SPINE, INC. NA 260700

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR CONFIDENCE KIT: (B) (4), LOT: CKHDBN