BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO CONNECTOR ADAPTOR

    MDR report key: 2891395 · Received December 21, 2012

    Report

    Report Number
    9617544-2012-00587
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, "3 CONNECTOR ADAPTORS FAILED TO WORK PROPERLY AND HOLD THE REDUCTION ACHIEVED FROM THE REDUCTION HANDLES. THE NUT THAT THREADS DOWN TO LOCK THE CONNECTOR AT THE DESIRED ANGLE GOT STUCK AND LOCKED UP. THIS WAS FRUSTRATING BECAUSE IT HAPPENED ON 3 DIFFERENT CONNECTOR ADAPTORS. THE RESULT WAS NOT GOOD. THERE WAS EXTENDED OPERATIVE TIME TO REPLACE THE 2 BROKEN CONNECTOR ADAPTERS, AND THEN MORE TIME WAS WASTED TO REVISE IT A SECOND TIME AND REPLACE THE THIRD CONNECTIVE ADAPTER THAT FAILED. ALSO, BY THIS TIME IN THE SURGERY, (B)(6) MD WAS NOT GETTING THE FX TO REDUCE AS MUCH AS IT DID WITH THE INITIAL REDUCTION AND RESTORATION OF HEIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO CONNECTOR ADAPTOR INSTRUMENT LXH STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK