BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM

    MDR report key: 3852830 · Received June 6, 2014

    Report

    Report Number
    0009617544-2014-00257
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED; RESULTS: THE SALES REP WAS MISINFORMED ABOUT THE CASE, AS THE REPORTED ROD DID NOT CONTRIBUTE TO THIS EVENT. CONCLUSION: CORRESPONDENCE WITH THE ORIGINATOR HAS CONFIRMED THAT NO ISSUE WAS IDENTIFIED WITH THE REPORTED ROD. THE REVISION SURGERY WAS PERFORMED DUE TO LACK OF FUSION BETWEEN TWO VERTEBRAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PHONE CONVERSATION THE SURGEON INFORMED THAT THERE HAD BEEN A REVISION SURGERY TO REMOVE A BROKEN ROD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PHONE CONVERSATION THE SURGEON INFORMED THAT THERE HAD BEEN A REVISION SURGERY TO REMOVE A BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331838 XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM IMPLANT-ROD MNH STRYKER SPINE-FRANCE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention