BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 60MM

    MDR report key: 2050014 · Received March 28, 2011

    Report

    Report Number
    9617544-2011-00116
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    THE RING AT THE BASE OF THE POLYAXIAL SCREW CRACKED AND ON INSERTION OF THE BLOCKER, THE HEAD LIFTED OFF THE THREADED SHAFT OF THE SCREW. ANOTHER DEVICE WAS IMMEDIATELY AVAILABLE AND SURGERY WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 60MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B02455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK