BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO LX SMALL CONNECTOR

    MDR report key: 2063990 · Received March 23, 2011

    Report

    Report Number
    9617544-2011-00108
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K052971
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCED 510(K) NUMBERS ARE: K062698, K070368. DEVICE STILL IMPLANTED IN PT SO WILL NOT BE RETURNED UNLESS IT'S EXPLANTED. ADD'L 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 "SMALL TRIO CONNECTOR CAME UNFASTENED FROM ROD. SURGEON HAS ELECTED TO NOT REMOVE IMPLANTS AT THIS TIME, BUT TO CONTINUE OBSERVATION OF PT PENDING ANY FURTHER DEVELOPMENTS. ORIGINAL SURGERY (B)(6) 2011".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO LX SMALL CONNECTOR IMPLANT MNI STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK