BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3850180 · Received June 5, 2014

    Report

    Report Number
    0009617544-2014-00249
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    January 26, 2011
    Report Date
    May 9, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW;RESULTS: DEVICE WAS REPORTED AS A CAGE, HOWEVER NO PRODUCT NAME OR CATALOG OR LOT #S WERE PROVIDED.CONCLUSION: A CAGE WAS REPORTED TO HAVE BEEN EXPLANTED AND IS NOW PART OF A PENDING LAWSUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT CERVICAL SPINE SURGERY ON (B)(6) 2011 WHICH INVOLVED A FUSION. THE PATIENT WAS ALLEGEDLY REVISED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT CERVICAL SPINE SURGERY ON (B)(6), 2011 WHICH INVOLVED A FUSION. THE PATIENT WAS ALLEGEDLY REVISED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329912 UNKNOWN_SPINE_PRODUCT UNKNOWN CERVICAL PLATE OVE STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention