BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N FIX II ROD 150MM

    MDR report key: 1158601 · Received September 12, 2008

    Report

    Report Number
    1719045-2008-00111
    Event Type
    Injury
    Date Received
    September 12, 2008
    Report Date
    August 15, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    NQP
    PMA / PMN Number
    K061774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: SYNTHES WAS INITIALLY NOTIFIED OF THIS EVENT ON APRIL 16, 2008, HOWEVER, THIS FOREIGN DEVICE WAS NOT CLEARLY ASSOCIATED WITH A SIMILAR US PRODUCT UNTIL AUGUST 15, 2008. THIS REPORT IS BEING SUBMITTED BASED ON THE AUGUST 15, 2008 DATE.

    Description of Event or Problem · 1

    PT IMPLANTED WITH AN N FLEX ROD REPORTEDLY FELL POSTOPERATIVELY IN 2008. X-RAYS TAKEN REVEALED THE ROD HAD BROKEN. PT WAS RETURNED TO THE OR ON AN UNK DATE FOR REMOVAL OF THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N FIX II ROD 150MM N FIX RODS NQP SYNTHES (USA) NA P06J01

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention