BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA POLYAXIAL SCREW 8.5 X 40MM

    MDR report key: 2097101 · Received May 2, 2011

    Report

    Report Number
    9617544-2011-00157
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K012027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    6 XIA BLOCKERS CATALOG #03756230 WERE USED AND DISCARDED BY HOSPITAL. IT WAS NOT REPORTED THAT THEY FAILED, MERELY WERE USED ON CONJUNCTION WITH THE SCREW TULIP HEAD THAT SPLAYED. THEY ARE NOT BEING REPORTED AT THIS TIME. THIS PRODUCTS WILL BE RE-EVALUATED FOR REPORTABILITY ONCE THE INVESTIGATION IS COMPLETE. ADDITIONAL PMA/510 K060361. 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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UPON BLOCKER INSERTION, TULIP HEAD SPLAYED AND THE BLOCKER WAS NEVER ABLE TO FULLY BE TORQUED DOWN. SO THAT SCREW WAS EXPLANTED ALONG WITH 5 OTHER BLOCKERS IN THE CONSTRUCT THAT WERE ALREADY TORQUED DOWN, THEN ANOTHER 8.5 SCREW WAS IMPLANTED ALONG WITH 6 MORE BLOCKERS. SCREW IS BEING RETURNED, BUT THE 6 EXPLANTED BLOCKERS WERE ACCIDENTALLY DISCARDED BY THE HOSPITAL STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA POLYAXIAL SCREW 8.5 X 40MM IMPLANT MNH STRYKER SPINE BORDEAUX NA 106910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization