BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N FLEX ROD 150MM

    MDR report key: 1812016 · Received August 18, 2010

    Report

    Report Number
    1719045-2010-00219
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    February 5, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    NQP
    PMA / PMN Number
    K061774
    Removal / Correction Number
    Z-0963/8-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN, INVESTIGATION NOT COMPLETE. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. THIS PRODUCT WAS THE SUBJECT OF A MEDICAL DEVICE RECALL; HOWEVER, THE INFORMATION DOES NOT REASONABLY SUGGEST ASSOCIATION WITH THIS EVENT.

    Description of Event or Problem · 1

    PT EXPERIENCED TISSUE GROWTH (OSSIFICATION) AT THE AREA OF THE DYNAMIC PART OF THE NFLEX-IMPLANT. PT HAS BEEN REOPERATED ((B)(6) 2010) AND ONCE AGAIN, THERE IS SOME TISSUE GROWTH VISIBLE. THE SURGEON ASSUMES THAT THERE MAY BE AN INFECTION. THIS IS 4 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N FLEX ROD 150MM N FLEX ROD NQP SYNTHES (USA) NA P07M03

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PANGEA SCREW