BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM R T R PARALLEL CONNECTOR TOP - SIDE

    MDR report key: 2860186 · Received November 21, 2012

    Report

    Report Number
    9617544-2012-00522
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K083393
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DR. (B)(6) WAS ADDING THE CONNECTOR TO THE CURRENT CONSTRUCT AND THEN TO THE NEW ROD FOR THE NEW CONSTRUCT. WHEN HE WENT TO TIGHTEN THE BLOCKER ON THE SIDE LOADING PORTION OF THE CONNECTOR (NEW ROD) IT WOULD NOT STOP ADVANCING DURING FINAL TIGHTENING. HE REMOVED THE CONNECTOR AND IT WAS VISIBLY BENT OPEN. HE TRIED A NUMBER OF DIFFERENT BLOCKERS IN THIS PROCESS ASSUMING THAT WAS THE PROBLEM, WHEN, IN FACT, THE CONNECTOR HAD BEEN BENT OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM R T R PARALLEL CONNECTOR TOP - SIDE IMPLANT NKB STRYKER SPINE BORDEAUX NA B10470

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR