BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED STRYKER IMPLANTS

    MDR report key: 2792328 · Received October 12, 2012

    Report

    Report Number
    9617544-2012-00438
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    October 19, 2007
    Report Date
    September 17, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RAQA MANAGER RECEIVED A LETTER WITH A LEGAL CLAIM: ¿A PATIENT, MR. (B)(6), AFTER AN INCIDENT, UNDERWENT A SURGICAL PROCEDURE OF STABILIZATION OF SPINE IN AN UNSPECIFIED POSITION.¿ THIS COMPLAINT WAS RAISED WITH A MINIMUM OF INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED STRYKER IMPLANTS IMPLANTS NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK