BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4"

    MDR report key: 2992713 · Received March 7, 2013

    Report

    Report Number
    1526439-2013-13351
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    GAA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONFIDENCE NEEDLE WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    THE CONFIDENCE NEEDLE BROKE OFF IN THE PATIENT'S VERTEBRAL BODY DURING A VERTEBROPLASTY PROCEDURE. THE BROKEN NEEDLE PORTION REMAINS ENCASED WITHIN THE VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98019 CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4" NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1