BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRODUCER NEEDLE, 13G SIDE HOLE

    MDR report key: 1587215 · Received January 8, 2010

    Report

    Report Number
    1526439-2010-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 10, 2009
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    DYB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE APPEARS TO BE DUE TO THE CEMENT HARDENING AROUND THE SIDE HOLE NEEDLE. WHEN FORCE WAS APPLIED TO ROTATE THE NEEDLE, IT CAUSED THE NEEDLE TO SHEAR. AS STATED IN THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, THE WORKING TIME FOR THE CEMENT IS BETWEEN 8-11 MIN. NEEDLE REMOVAL WAS REPORTED TO HAVE OCCURRED AT 13.5 MIN.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A PERCUTANEOUS VERTEBROPLASTY ON LEVEL T5 USING A BIPEDICULAR APPROACH WITH TWO SIDE HOLE NEEDLES. AFTER INJECTING THE CEMENT, HE BEGAN PROCESS OF NEEDLE REMOVAL. THIS WAS 13.5 MIN. SINCE CEMENT WAS MIXED. HE ROTATED THE NEEDLES SEVERAL TIMES IN PLACE THEN PULLED OUT THE FIRST NEEDLE NOTING THAT THE TIP WAS BROKEN OFF IN THE V-BODY. HE REMOVED THE SECOND NEEDLE AND IT WAS INTACT. TIP OF ONE NEEDLE REMAINS EMBEDDED WITHIN THE BONE OF THE PATIENT. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE INTRODUCER NEEDLE, 13G SIDE HOLE INTRODUCER NEEDLE DYB DEPUY SPINE, INC. NA CJNB2H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK