BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS TL SPAER 9 X 30 X 4 DEG

    MDR report key: 2894508 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00595
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MQP
    PMA / PMN Number
    K042571
    Removal / Correction Number
    N
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.

    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, "IMPLANT BROKE AT THE INTERFACE BETWEEN THE IMPLANT AND THE INSERTER... DURING INSERTION OF THE IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS TL SPAER 9 X 30 X 4 DEG IMPLANT MQP STRYKER SPINE BORDEAUX NA 45942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK