BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NFLEX CURV 1SEGM L55 PCU/TAV-ELI

    MDR report key: 3569284 · Received January 12, 2014

    Report

    Report Number
    3003506883-2013-00414
    Event Type
    Injury
    Date Received
    January 12, 2014
    Report Date
    November 4, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: NQP. IMPLANTED ON AN UNKNOWN DATE IN 2012. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGERY PERFORMED IN 2012,ON AN UNKNOWN DATE, USING A CLICK'X AND NFLEX STABILIZATION OF L4-S1, HAD VERY GOOD FUSION, BUT ON AN UNKNOWN DATE IN 2013, A SCREW HEAD CAME OFF FROM AN IMPLANT AT L5 THAT REQUIRED THE PATIENT TO UNDERGO A SECOND SURGERY WITH A T-PAL CAGE TAN BETWEEN L4/L5 AND CLICK'X SYSTEM WITH TITANIUM RODS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22298 NFLEX CURV 1SEGM L55 PCU/TAV-ELI NQP SYNTHES ELMIRA 6459245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention