BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 2152323 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00219
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. WARNER WAS FUSING FROM L4-S1. PEDICLE SCREWS WERE PLACED AT EACH LEVEL. A 4.5X600 VITALLIUM ROD WAS CUT AND BENT. A CORKSCREW PERSUADER WAS NEED TO PERSUADE ROD TO SCREW HEAD. A BLOCKER WAS PLACED IN THROUGH THE PERSUADER AND PERSUADER WAS REMOVED. THE BLOCKER POPPED OFF THE SCREW HEAD WHEN THE PERSUADER WAS REMOVED. THE BLOCKER WAS CROSS THREADED AND NEW BLOCKER WAS USED WITH THE ROD FORK. THE BLOCKER WAS SEATED AND FINAL TIGHTENED WITHOUT ANY FURTHER INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA 2P9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK