BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 5654897 · Received May 13, 2016

    Report

    Report Number
    0009617544-2016-00185
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    STRYKER SPINE-US
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW, DEVICE INSPECTION, COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED BECAUSE NO DEVICE AND/OR INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; A PATIENT REPORTED HAVING A C1-C2 IMPLANT FROM STRYKER SPINE WITH BONE GRAFT APPROXIMATELY 1 YEAR AGO. IT WAS REPORTED THAT THE PATIENT, NOTIFIED THE STRYKER TEAM OVER THE PHONE THAT HE WAS CONCERNED THAT THERE COULD BE A BRAIN DIFFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; A PATIENT REPORTED HAVING A C1-C2 IMPLANT FROM STRYKER SPINE WITH BONE GRAFT APPROXIMATELY 1 YEAR AGO. IT WAS REPORTED THAT THE PATIENT, NOTIFIED THE STRYKER TEAM OVER THE PHONE THAT HE WAS CONCERNED THAT THERE COULD BE A BRAIN DIFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308291 UNKNOWN_SPINE_PRODUCT UNKNOWN SPINE PRODUCT KWP STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other