BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-HANCE ROD

    MDR report key: 1360150 · Received January 9, 2009

    Report

    Report Number
    2520274-2009-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Report Date
    December 10, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    NQP
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. IMPLANT DATE REPORTED AS 2008. SUBJECT DEVICE REMAINS IN THE PT. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. CANNOT BE DETERMINED WITHOUT A CATALOG NUMBER OR LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH N-HANCE RODS AND PANGEA SCREWS AT L4-S1. RIGID LEVEL WAS L5-S1. ABOUT 2 WEEKS POST OPERATIVE, PT COMPLAINED OF NEW PAIN. X-RAY TAKEN AT 3 WEEKS POST OPERATIVE SHOWED BOTH RODS HAD SLIPPED OUT OF THE SCREW HEADS AT S1. PT IS CURRENTLY ASYMPTOMATIC AND SURGEON HAS NO PLANS TO REVISE AT THIS TIME. THIS REPORT IS ONE OF TWO REPORTS FOR THE SAME INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N-HANCE ROD N-HANCE RODS NQP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREWS